Today we announced that the US FDA has cleared IND applications for @4dpharmaplc’s #LiveBiotherapeutics MRx0005 and MRx0029 for the treatment of #Parkinsons, and Phase I trial in patients is expected to commence mid-2022
MRx0005 and MRx0029 are two unique single strain Live Biotherapeutic candidates, which have been shown pre-clinically to have positive impacts on multiple key aspects of Parkinson’s disease pathology, including gut barrier integrity, neuroinflammation, oxidative stress and neuroprotection. In animal models of Parkinsonian syndrome, 4D pharma demonstrated that MRx0005 and MRx0029, respectively protected against the loss of dopamine metabolites and dopamine-producing neurons in the brain.
Interesting. Addressing PD through the gut. Fix the gut, fix the brain (if it works):
"About MRx0005 and MRx0029
MRx0005 and MRx0029 are oral single strain Live Biotherapeutic products in development for the treatment of neurodegenerative conditions such as Parkinson’s disease via the gut-brain axis. Discovered using 4D pharma’s MicroRx® platform, both have been shown pre-clinically to reduce neuroinflammation including inflammation induced by α-synuclein, and to protect neurons from oxidative stress-induced death. MRx0005 has been shown to upregulate expression of neuroactive molecules and their receptors in vivo, and protected against loss of dopamine metabolites in the brains of mice with induced parkinsonian syndrome. Impaired intestinal barrier function and intestinal permeability is a common symptom of Parkinson’s disease thought to potentially contribute to the onset or progression of the condition, and MRx0029 has been shown to improve intestinal epithelial integrity. MRx0029 has also been shown to induce the differentiation of dopaminergic neuronal phenotype in vitro, and in an animal model of Parkinson’s disease protected against the loss of dopaminergic neurons. In 2022, 4D pharma plans to commence a Phase I clinical trial of both MRx0005 and MRx0029, separately, in people with Parkinson’s disease."
Let's read more! In vitro Characterization of Gut Microbiota-Derived Bacterial Strains With Neuroprotective Properties 2019 researchgate.net/publicatio...
"Neurodegenerative diseases are disabling, incurable, and progressive conditions characterized by neuronal loss and decreased cognitive function. Changes in gut microbiome composition have been linked to a number of neurodegenerative diseases, indicating a role for the gut-brain axis. Here, we show how specific gut-derived bacterial strains can modulate neuroinflammatory and neurodegenerative processes in vitro through the production of specific metabolites and discuss the potential therapeutic implications for neurodegenerative disorders. A panel of fifty gut bacterial strains was screened for their ability to reduce pro-inflammatory IL-6 secretion in U373 glioblastoma astrocytoma cells. Parabacteroides distasonis MRx0005 and Megasphaera massiliensis MRx0029 had the strongest capacity to reduce IL-6 secretion in vitro. Oxidative stress plays a crucial role in neuroinflammation and neurodegeneration, and both bacterial strains displayed intrinsic antioxidant capacity. While MRx0005 showed a general antioxidant activity on different brain cell lines, MRx0029 only protected differentiated SH-SY5Y neuroblastoma cells from chemically induced oxidative stress. MRx0029 also induced a mature phenotype in undifferentiated neuroblastoma cells through upregulation of microtubule-associated protein 2. Interestingly, short-chain fatty acid analysis revealed that MRx0005 mainly produced C1-C3 fatty acids, while MRx0029 produced C4-C6 fatty acids, specifically butyric, valeric and hexanoic acid. None of the short-chain fatty acids tested protected neuroblastoma cells from chemically induced oxidative stress. However, butyrate was able to reduce neuroinflammation in vitro, and the combination of butyrate and valerate induced neuronal maturation, albeit not to the same degree as the complex cell-free supernatant of MRx0029. This observation was confirmed by solvent extraction of cell-free supernatants, where only MRx0029 methanolic fractions containing butyrate and valerate showed an anti-inflammatory activity in U373 cells and retained the ability to differentiate neuroblastoma cells. In summary, our results suggest that the pleiotropic nature of live biotherapeutics, as opposed to isolated metabolites, could be a promising novel drug class in drug discovery for neurodegenerative disorders."
(Note: It has been suggested that my understanding of this is wrong. I’m waiting for Pooh Bear to explain what I have incorrect. I’m really trying to understand this)
MRx-0029 is comprised of Butyrate and Valerate, both are SCFA. Valerate is either the same as or closely related to pentanoate.
There is increasing evidence that PD is akin to an autoimmune disease. My current hypothesis is that PD is initiated by an autoimmune response to pathogens in combination with mitochondrial dysfunction due to inflammation and often an epigenetic / genetic predisposition.
In this paper from Nature, it is stated that pentanoate suppresses autoimmunity. Pentanoate I believe = Valerate
Valerate combined with Butyrate is the combo in MRx-0029.
Pooh, you recently referred to me as someone who thinks they know everything and you find tiresome. According to you I’m a “yipping chihuahua” I’m “overly sensitive.” I take myself “too seriously”. I “need to lighten up.”
Interacting with you is emotionally unhealthy for me.
You mock strangers online and scold and berate a man whose almost 90.
But since YOU KNOW EVERYTHING, I look forward to reading your explanation because I am here to learn.
If MRX-0029 is NOT comprised of Butyrate and Valerate then, what is it comprised of?
Click on image to read the all knowing Pooh proclaim he knows everything. What a great resource! Everything! Or is he full of….
Pooh’s Pooh
• in reply to
Quote from this link, “MRx 0029 methanolic fractions containing butyrate and Valerate showed anti-inflammatory activity.”
Methanolic means “obtained with the use of methanol.”
If MRx 0029 is not comprised of butyrate and Valerate, both being SCFA, are they a biproduct or result of it?
What is it comprised of then?
SCFA are accessible or the means of encouraging their production is. If this promising therapeutic is promising bc of SCFA that could be possibly achieved by other means, isn’t that worth determining?
It's a famous quote. On any number of posters. A joke. Most people can recognise that (although autistic people take things literally and struggle with that type of humour) Have you any idea what MRx-0029 is?
Now you are implying I’m autistic because I did not know this quote. Obviously I did not take your proclaiming that you know everything literally. Trust me, your actually “knowing everything” is not something that even entered my mind. But you do like to derail threads and I’m trying to get you to respond with information of actual value. I did not know chihuahuas could have autism. Haven’t given much thought to that.
Are you going to explain MRx-0029 or just respond with insults?
I know the latter is more your forte.
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(Editing bc I’m not going to allow myself to be squeezed off. )
Verbal abuse says much more about the abuser than the recipient.
Implying I’m autistic is so cruel and low.
Calling me a yipping chihuahua.
Your sarcasm and making fun at my expense.
I’m obviously really trying to learn.
Why respond just to be mean? Stop commenting than! Why can’t you just leave me alone?
I’m in contact (off this forum) with two people who left because of the incivility on here. I’m sure there are many others.
Not at all. You brought the quote up again gratuitously and with no relevance for perhaps the 5th or 6th time so it seemed appropriate to share with you its origin and the context in which it was used.There are degrees of autism. My wife taught in a school for special needs so we have a fair bit of experience. It is a feature that people with a degree of autism fail to appreciate humour and irony. They are very literal (often brilliant and creative, but literal)
MRx-0029 is a bacteria. One of the Parabacteroides. Sort of probiotic. Hence the "live" oral administration, gut-brain axis, stuff.
Don't go cc. There're some serious psychological issues with people who use passive aggression while gaslighting and won't leave you alone despite you repeatedly asking politely. Just ignore them. Many people benefit from your research on this forum.
I'm sure most lurkers 💕 you and be disappointed to see you leave!
"MRx0005 and MRx0029 are single strains of gut commensal bacteria that have been derived and isolated from healthy human donors. The bacteria are then grown from cell banks and encapsulated for oral administration and selective delivery to the gut."
Valeric acid is a major compound of Valerian which is easily accessible. Valeric acid and Butyric acid are stated as what MRx-0029 create or facilitate the making of.
This can’t be right or can it? The bacteria used in the trial is intended to make SCFA that are already accessible?
Am I wrong about the Valeric acid? “Valeric acid is a major compound of valerian.” Is stated in the paper
“Valerian may play a role in epigenetic gene regulation.”
Valerianella locusta, known as Soncino (also Songino) or simply Valeriana (Valerianella locusta (L.) Laterr.) is a herbaceous species belonging to the Valerianaceae family.
Valerianella locusta is a vegetable that can be eaten in salads, similar to lettuce and chicory (radicchio).
This plant is often indicated for those who are weak in the stomach, because it has a high digestibility.
The best organoleptic characteristics are found in young plants and its soft leaves; adult valerianella plants are consumable after cooking.
This plant has a discrete content of vitamins A, B and C, potassium, calcium, phosphorus, iron which make it a very important food of balance in growth; it also helps to defend against infections and benefits the skin.
The main properties of this plant are: purifying, emollient and laxative.
A dietary form?! Hooray! I’m going to seek it out. I like to look at what is in meds or supplements then see if I can try to find the same via diet. I think can direct us towards what we need in our diet most.
It sounds like it’s not difficult to grow. Make our own tea?
This may help answer the question. Remember Dr. Fitzgerald chose to use Lactobacillus plantarum to increase the circulating methyl folate in her study participants instead of choosing to simply supplement methylfolate nor other isolated nutrients? That was to maximize the circulating nutrient bioavailability and symbiotic benefits derived from microbiome gene regulation via "orthomolecular" diet.
The concept is similar. While you can certainly choose to consume readily available SCFAs, the effect will be more or less transient and cannot compensate for the complex benefits attained through an interplay of microbiome diversity. You should aim to increase the circulating SCFAs through endogenous production by feeding your beneficial gut bugs and creating an environment so that they thrive to choke out the pathogens responsible for dysbiosis and heal the intestinal barrier. I agree with Gioc that this most likely can't be attained through limited strains of probiotics and you're much better off correcting deficiencies and a diet full of inulin, FOS, resistant starch (sprouted barley/rye, etc), pectins, etc. Acetate, propionate and butyrate will do most of the heavy lifting while the rest SCFAs including valerate make up less than 5%. frontiersin.org/articles/10...
Yes, supplementing does have its place and especially viable marketing concept for those who do research for future profits. In fact, in many cases, targeted supplementation helps speed recovery and is needed to correct major deficiencies (think thiamine). Yes, changing diet is drastic, expensive and inconvenient and not feasible for everyone unless hugely motivated and willing to learn something about nutrition. Not an easy task and everyone wants a simpler solution.
I just noticed your edit. True not everyone responds well to a certain specific diet as your methylation needs differ. However, I truly believe food diversity through careful introduction tends to help practically everyone unless you have developed an allergy, such as gluten or shellfish. I thought I was lactose intolerant at one point in my life (after antibiotics) but that wasn't the case at all. Through a slow introduction, you build a gut microbiome that produces the enzymes to help digest lactose. For someone who's been doing a ketogenic diet or LCHF diet, reintroduction of complex carbs will need to be very slow and steady or you'll definitely feel unwell on glucose spike or due to a compromised gut barrier.
Don't expect WTP to elaborate on natural substances/vitamins/minerals. Do MDs know/support alternative medicine? Maybe some who got sick of the system and moved on to actually help people rather than "killing" them with meds.
WTP mocks everyone who uses anything other than traditional meds. Don't stress yourself out to WTP.
I was wrong. MRx-0029 is not comprised of SCFA, it produces them. “Butyric, Valeric, hexanoic acid.”
“Butyrate and Valerate induced neuronal maturation but not to the same degree as the complex cell-free supernatant of MRx-0029.”
So,
We can just wait years for this MRx-0029
Or
Determine if there is a way of increasing Valerate and butyrate which so far looks to not be as beneficial but beneficial nonetheless.
I write here but I address WTP and CC alike. But MRx-0029 content isn't a trade secret? I say this only for the precision, very precise.
But this abbreviation MRx-0029 which means, because it is familiar to me.
I know you must have been friends in the beginning before being so enemies now.
Go ahead!
but you will get hurt and in the end you will carry it inside ... forever. Unless, in the end, you restore mutual respect as befits old friends who share the same destiny in the time.maybe.
Post Scriptum: IMHO this probiotic, below in the link, does the same thing and is very good as probiotic.
Thank you Gio. From what I’ve just read, Clostridium Butyricum produces a high volume of Butyric acid. But what about SCFA, Valerate? The bacteria, MRx-0029 facilitates the production of both.
And Gio, I’m not “enemies” with anyone. I do not carry that emotional burden.
I will not lower my standards of basic decency to be “friends” with a bully.
My children’s kindergarten classroom had a list of classroom rules that could be beneficial to this forum.
My stance on name calling, taunting, disrespect, telling other members they “shouldn’t be online.” are “too sensitive” refusing to stop, etc etc. is inappropriate. I will never waver on this and not just for my sake but for the sake of the forum in general.
Online bullies do not get my respect let alone my friendship. My conscious is clear.
Circling back to the actual subject,
Is it possible and could it be beneficial to increase our production of the SCFA Valerate?
The point is not that there may or may not be a persons who offends, that there will always be.
The point is, he can't hit us without you wanting to or partially agreeing with that person at some point or purpose.
Fighting does not mean taking proper care of others and oneself.
This is the sense of the previous friendship which was a situation of "taking care" that becomes "fighting".
These situations do not evolve like this without a specific will, that is a series of decisions that can be changed .
... If desired..
.. Now.
There has been a lot of discussion about HUCP on this topic of probiotics and there still is, IMO there is a lot of marketing in these things and it confuses the subject a lot. So I don't know, but nobody else knows. The only thing I think is that the long-term use of probiotides is not sustainable, much more viable to use vitamins and diet.
only a diet rich in fiber and the high-vegetable thai traditional diets in Thailand is a work of culinary art ... downgraded to "healthy spices".
Diet is the known way to increase valeric acid. In the context of the digestive system it is difficult to control the composition of bacteria and can even be dangerous. However, here is how: nature.com/articles/s41598-...
If you like to fight and win easy, this argument is not suitable, it is more "peace and love" and peasant pragmatic wisdom.
you didn't offend me, I was just joking a little because honestly I have found organic chemistry very boring since high school, I prefer the art of cooking.
I knew that reference to 'Thai traditional diets' was not random. So thank you for this paper, which just confirms all that we know - eat your vegetables.
Case in point: I eat more vegetables than my spouse. And I am not the one with PD.
Just yesterday I was accused of 'shoving greens' down her throat. The greens amounted to two lettuce leaves. I kid you not.
Just remember that it is vegetables that got Terry Wahls, MD out of her wheel chair.
The fight to promote vegetables in this household continues.
the fact is that we live in an age where everything is strongly oriented by money and marketing. Here we find two bacterial strains that are, according to the narrative here, two superheroes with special powers and thanks to a new nomenclature and rules are patentable. Wow this is fantastic , but in a financial context. In a medical context it is for now only a weak promise because what matters is the result. I continue to take my Pentanoate or valeric acid through the good valerian of Soncino Italia, a typical area, because I find it much more fun to practice the ‘high-vegetable thai traditional cuisine’ than to read the advertisements.
Prior to PD I ingested masses or veges and “healthy” beans, lentils, and whole grains. I had spinach smoothies almost daily. I think all the lectins and the excessive iron bay have contributed to my young onset.
I find trials so interesting in part because, for example, if they have determined that helping our gut create butyrate and Valerate is so important that they will invest millions then that is a sign that we should try to achieve that.
The question: Is there anything else that can increase Valerate?
And 'pay tell' what is Valerate. Valerate, Wiki tells me is a short chain fatty acid, of which there are five
Formate Acid (C1)
Acetic Acid (C2)
Propionic Acid (C3)
Butyric Acid (C4)
Valeric Acid/Pentanoate (C5)
And where do these compounds come from and what is their importance?
Derived from intestinal microbial fermentation of indigestible foods, SCFAs are the main energy source of colonocytes, making them crucial to gastrointestinal health.
The focus then is on gastrointestinal health, which is crucial for Parkinson's.
Valerian root (Valeriana officinalis) is a popular and widely available herbal supplement used to treat sleeping disorders and insomnia...valeric acid can decrease the breast cancer cell proliferation possibly by mediating epigenetic modifications such as the inhibition of histone deacetylases and alterations of DNA methylation.
This from the paper
Valerian and valeric acid inhibit growth of breast cancer cells possibly by mediating epigenetic modifications
The short-chain fatty acid pentanoate suppresses autoimmunity by modulating the metabolic-epigenetic crosstalk in lymphocytes
...pentanoate (Valeric Acid/C5) shows a potent histone deacetylase-inhibitory activity in CD4+ T cells, thereby reducing their IL-17A production...Taken together, by enhancing IL-10 production and suppressing Th17 cells, the SCFA pentanoate might be of therapeutic relevance for inflammatory and autoimmune diseases.
So the Valerian herb, native to temperate regions maybe your target.
It contains volatile oils. These oils give Valerian a pungent odor due to the release of isovaleric acid (C5) - a straight-chain saturated fatty acid containing five carbon atoms.
Can I read this as 'supplementing with valerian supplies valeric acid/pentanoate and therefore promotes gut health, in addition to its well know function as a sleep aid'?
Valerian! When I realized it could be as easy as valerian it seemed too good to be true. It was the breast cancer paper that got me excited. Interesting that the MRx-0029 refers to it as pentanoate instead of the more widely used term Valeric acid. It’s accessible! And, sounds to be somewhat bio available. I understand that MRx-0029 may be better bc it leads to the body creating its own valerate but, a widely used safe supplement to increase valerate sounds like a potentially good idea. Thank you for summarizing this so well! And thank you for researching it so well! What do you think? Do you think she should try it? Did you see my spermidine post? I wonder your opinion on it?
I have two expired bottles of Valerian from 2017. For an unknown reason, it doesn't help me with sleep and causes insomnia. Although the herb initially helped my late mother sleep, it stopped working for her as well. Also, the herb acts on GABA receptors to inhibit an enzyme that destroys GABA and increases the amount of GABA in CNS. If our recent discussion under the below thread holds true for the Korean research on astrocytic excess GABA, then this is not what you want.
Anything in excess and out of balance is "bad" and I'm sure this depends on individuals and no universal efficient cure exists. This is why patching the holes on your own roof for your own causes based on your history matters more than tunneling on one plausible solution.
We are miscommunicating. I never said or even alluded to there being one plausible solution. Yes, Out of balance, a lack of homeostasis is the cause of disease. Yes, it is highly individual. And yes, diet is first and foremost. I’m just enjoying learning about the science. “Tunneling on one plausible solution.” No, I’m not.
Anyways, I find it interesting and I make no claims of having any answers just a lot of questions and I enjoy the learning process.
I'm not trying to accuse you of anything and know you're looking into all aspects of healing, but you must admit that you're focused on researching valeric acid, a minor SCFA by an association that may be inconsequential in the whole scheme.
Here's an interesting study you might be looking for as it measures valerate levels depending on food intake in association with obesity - the results vary depending on microbiota compositions.
The pharmacology of substances (how drugs work in the body), its pharmacokinetics and pharmacodynamics is way beyond me.
And then there is this as it relates to LiveBiotherapeutics MRx0005 and MRx0029, '....the pleiotropic nature of live biotherapeutics, as opposed to isolated metabolites, could be a promising novel drug class in drug discovery for neurodegenerative disorders.'
Notwithstanding the above Valerian Root is a recognized herbal supplement. So give it a try and see how it works.
As for the spermidine post, I will leave it to park_bear .
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Short Chain Fatty Acid supplement is patent pending. Sharing this here bc the trial pored is based on beneficial SCFA being produced. (At least that is my understanding )
As noted in my profile I am convinced that the gut brain axis is a major factor in PD and hence a major opportunity for effective therapy. And as a former Director of a probiotic research company, I have a long standing interest in the microbiome (our biggest organ) generally. Both Parabacteroides distasonis and Megasphaera massiliensis appear to be excellent candidates individually, but even more interesting in combination. It's not clear whether the proposed phase 1 will also look at both in combination or just individually
Nor is there any timeline to authorisation I can find, although the implication is an accelerated path to clinical availability. If they have Merck as a partner (MSD in the UK, my Dad's alma mater) then they have the bucks, the nouse and the experience to push this through.
Nor am I clear why bacterial strains identified and extracted from screened human sources require fda authorisation for oral administration any more than by FMT
However, it seems clear that the pleiotropic nature of the bacteria, as opposed to just the scfa's that they produce, offer quite exciting therapeutic potential and that this could be of great value
You could be forgiven for thinking this thread was about impending clinical trials for a therapy using live bacteria. Thank heavens nobody had the bad manners to hijack it for a general chit chat about whatever interested them
just to bring the discussion back where you ask, could you explain to me what it means and from what reference data you derive your clarity regarding this your statement: "However, it seems clear that the pleiotropic nature of the bacteria, as opposed to just the scfa's that they produce, offer quite exciting therapeutic potential and that this could be of great value ".
It concludes that the combined effects of several factors the live bacteria produces, are more important than individual ones
"The whole is greater than the sum of the parts"
If you like, as a heavy paraphrase
"although one of the tests we do on bacteria is a sort of spectrum analysis of the scfa that are produced by the bacteria, (cos we know scfa's themselves are usually good things) when we tested just the effects of the scfa's in question, although a couple of them showed they did the same good stuff, it wasn't in the same league as the overall, combined effects of the bug"
Pleiotropic strictly refers to "producing more than one effect especially : having multiple phenotypic expressions a pleiotropic gene"
long and difficult reading is not in my nature and so I deepened.
The "discussion" chapter was enough to understand that our two superheroes with special powers (pleiotropic effect) are more suggested than observed in the research itself. A nice intuitive postulate, after all this is how the discoveries are made and I quote:
"Overall, we have demonstrated that MRx0005 and MRx0029 affect host function differently in different types of brain cells, with distinct effects on inflammation and neuronal cells. is that the cells we have used in this study are either immortalized or derived from tumors. This choice was made to assure a reproducibility of the data at this stage of the project.More investigation using primary microglia cells and neurons are undoubtedly necessary and planned to further understand thebiological meaning behind our fi ndings.We postulate that the effects observed on neuro inflammation and oxidative stress are mediated by bacterial production of different classes of metabolites. SCFAs produced by gut bacteria are typically recognized as positive modulators of host functions. intake by epithelial cells and play an important role in the proliferation differentation and regulation of epithelial cells (Wation, byfferng et al., 2019). ...
omitted
... MRx0029 is a histone deacetylase (HDAC) inhibitor throughits production of butyrate, as shown in a research paper recently published by our group (Yuille et al., 2018). Wakade and Chong investigated the neuroprotective mechanisms of butyric acid in the context of Parkinson's disease by analyzing the relationship between the niacin receptor and dopamine levels (Wakade andChong, 2014). Butyric acid has the potential to bene fi cially impact Parkinson’s symptoms by reducing inflammation, increasing dopamine synthesis (by improving the amount of free niacin that is available for dopamine synthesis) and boosting mitochondrial
function to provide cells with more energy (Donohoe et al., 2011; Bourassa et al., 2016). Our findings highlight how the activity of a specific combination of SCFAs can affect neuropathologicalaspects of NDDs and how the use of LBPs rather than the single purified metabolite could be therapeutically successful. "
But thanks! we already knew this. And. Here we deal with in vitro research which determines how these strains affect inflammation especially on cytochines il6 and il8, In my opinion and I will be tranchant,
nothing special, even a good diet and some niacin does ... in vivo!
Given your scientific understanding of this, and my ignorance, if Valerate and butyrate are not relevant to MRx0029, please explain. I thought MRx0029 is beneficial bc it facilitates the production of those SCFA? Butyrate is so widely known and discussed I thought learning about Valerate has some relevance.
If trying to determine that is just “chit chat” I do apologize. My intention was and is to understand it.
Please, since you have reduced my efforts to chit chat, can you explain the Science of why my intention as stated above is not valid?
And if Valerate is inconsequential then why would a new means of creating butyrate be of such interest to you when there are so many easier ways of producing butyrate already?
Nedim, my initial comments were intended to figure out the reason why these therapeutics are being studied and what they result in. And if the end result could be achieved to any degree before such a therapeutic is available, I thought that was worth looking in to. And the live therapeutics being pursued appear to result in an increase is specific SCFA. So, I then sought to better understand the lesser known Valerate.
If you, the original poster found this to be inappropriate and “general chitchat” as someone stated, I do apologize to you.
I personally find it interesting that ( I think) the intention of MRx0029 is to increase butyrate and Valerate.
Maybe doing what we can to increase these SCFA now before the new therapeutic technology is available, is not just chit chatting and is worthwhile pursuing.
Valerate being found in easily accessible valerian is related to the MRx0029 research. maybe it is worth pursuing or maybe my well intended efforts are just chit chat.
Out of respect and appreciation for your research and posts, I apologize if I took it in a direction that only I found beneficial.
• in reply to
I do not mind. People get excited and carried away. It's ok. I hope we get results from the trials....
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