Campaign for cancer treatment FDA fast track

[Kiss_my_grits]

Regarding ErSO...Systems Oncology reports being ready to move forward with human trials but needs FDA clearance. So I started a campaign to help fast track ErSO. Please complete the form, sign and share.

change.org/p/fast-track-hum...

[Hidden]

Done! Thank you for your efforts/advocacy!

[bracelets1]

Just signed, shared and donated! Thank you for doing this for all of us!!!

[Trissh]

Done and donated! Thanks for your efforts! Also go to FDA Center for Drug Evaluation and Research (CDER) and complete that form as well. --Trish

[Kiss_my_grits in reply to Trissh]

Thanks, Trish. Do you have that link?

[Trissh in reply to Kiss_my_grits]

accessdata.fda.gov/scripts/...

[Kiss_my_grits in reply to Trissh]

Thanks. I think that’s the same link in the petition??

[Silver126]

Done and shared! A big hope

[Aquamoron]

Done!

[Tolife_18]

Thank you for your initiative. Unfortunately, I wasn’t able to open the link. Still, I’d like to say that fast track designation can be only filed. by the track company, usually after Ph1-2 results showing that drug is effective and safe.

Working in the pharma, I know that the company needs to submit documentation with pre-clinical results, submit an IND and the protocol for a future human study (Ph1) and wait 30 days for the FDA response. If none received, the company can move with the Ph 1 human study. Of course, if theare any questions regarding the protocol, it should be addressed

It’s a promising drug and I hope it’ll be successful for us and millions other MBC patients.

[Kiss_my_grits in reply to Tolife_18]

I was informed (3rd party, not directly from systems oncology) that pre clinical and IND have been submitted and the waiting period for approval is 9 months. Many do not have that kind of time.

[Tolife_18 in reply to Kiss_my_grits]

Agree that waiting period of 9 months is strange. Perhaps, the FDA requested that system oncology needs to do another study. Are you aware of any available publications on the topic?

[BluHydrangea]

Done.

[Hopeful4Cure]

Hello and thank you for sharing this with us. I signed, what I thought was the same petition about a month ago and that petition needed 35k signatures. It was about ErSo too. What is the difference between that one and this one? Who is Maggie Fogel? Is she on this forum? Where do the donations actually go? Ireally do not understand how this process works, but since it is the second petition I would like more details. I did sign the CDER too, put I do not understand how that can help directly, as that link to sign is only for questions and clearly states that - Information about drug products currently in review at FDA is confidential. If you know the manufacturer/sponsor, please contact them directly. We try to respond to each question within 24 to 48 hours.

[Kiss_my_grits]

Great questions. I am Maggie Fogel and I have MBC. I am also in a group for patients specific to the development of ErSO. In that group, another member connected with David Shapiro, a lead developer of ErSO. When she asked what we as patients could do to help the development of the drug he encouraged advocacy for FDA fast track. So I created this petition. My main goal was for people to complete the form directly to the CDC, but I realize people may not take those steps, hence the petition. The first one was a tremendous success and the creator followed up in sharing it with Systems Oncology and the US government. I was responding to the specific need at this specific time. And TBH, my hope is that someone with influence sees it and feels compelled to take some action.

[Hopeful4Cure]

Thank you for your clarification. I have been reading all about Erso, the pullouts from the pharma, etc. I am also aware of the UOI and Mr. Shapiro. I am sure that I am not the only one concerned about WHY these prior pharma companies pulled out and did not give a clear and concise answer. I am surprised that Danny Goss has not responded recently or Tammy, whom gave us the initial update last year and up to a few months ago. We have a hill to climb. Such a promising drug - 9 months is ridiculous to have to wait, all the pharma drugs were fast tracked super fast for COVID. Your concern, my concern and all the others that have been living with MBC, not once, not twice, but many times the mets come back. It is a ride we are all tired of taking, as it breaks us down. Wish we could get the media involved too, but many do not want to touch this because of the millions the pharm companies will lose, with this drug being approved not just for us MBCp's, but it could benefit many other groups. We really need to get the word out. Where do all the donations go? Where did all the donations go last time with the 35k signatures needed from the FB group? If 35k people donated just $1, that would be $35k -many donated much more and we never hear from those individuals about where the donations have actually gone. Thank you for the info.

[Kiss_my_grits in reply to Hopeful4Cure]

I didn’t remember seeing anything about donations when I set the campaign up. So I’m assuming they remain with change.org

I’ll read up on it and let you know. Sorry for the delay, I’m swamped at the moment.

[Hopeful4Cure]

Oh, I see. After you posted your request, others replied to you, that signed up and also stated they donated. It is interesting because it states on change.org, that IF your petition WINS, they use the money on platforms to gain attention. However, from the same ErSo petition from last year and this year asking for 35k signatures, I have not seen any advertisements or media placements. I am also trying to find the articles on the fast track - Who is the 3rd party and like Tolife_18, I too would like to know where this information is being published on the topic. We all thank you for the information. You had stated in your first post I think that Systems Oncology reports that they are ready to move forward with human trials. Where is this information?

[Kiss_my_grits in reply to Hopeful4Cure]

I found this on the change.org websitechange.org/l/us/chipping-in...

Much like what you described.

I’ve seen nothing publicly stated re the current state of ErSO, except that it is still in the works and they believe they can bring it to market. This lack of full disclosure seems typical of pharma and developers. My information came from a fellow MBC patient in the onco drug development industry. I wish there was more concrete information to cite. But the fact that it continues to be in the works following the Bayer pullout gives me confidence they are onto something.

[Hopeful4Cure]

Here is the orginal link from last year. change.org/p/systems-oncolo... and it is just short of 200 or so signatures as of today.

[Hopeful4Cure]

Ok, thanks for the info. That link above is original and the woman that started it states the petition for fast track trials, which she started last year. Now there are only 38 votes needed for the 35k. You get the hopes up for lots of people when you wrote (Regarding ErSO...Systems Oncology reports being ready to move forward with human trials but needs FDA clearance.) and now you say it is from a friend in the industry that told you that. Reported speech that is not validated is a let down for so many of us that are holding on to ErSo actually being fast tracked for human trial. The problem with change.org and that chipping in, which I have seen, says a lot, but I have never, ever seen anything promoted by change.org and they never tell us what specific platforms they are using. I am curious to see what happens when this original petition for ErSo fast track obtains only 35 more signatures, after nearly a year to get to the 35k mark. Should happen today!