retrotope

[JBOVERT]

RETROTOPE IS NOT GOING TO DO A CLINICAL TRIAL IN THE USA BUT INSTEAD HAS DECIDED TO DO IT IN EUROPE!

This is quite a set back as they are now saying that they probably will not resume with a clinical study in the use for 2 1/2 yrs! This is devastating news for those people that are suffering from MSA and PSP....there should be a law that prohibits these people from going outside of the continental United States!a

[sharoncrayn]

Why?

Pandemic, Funding issues and new Chairman of the Board, plus resignation of CEO. A very small biopharm with one trick pony ... RT001.

PSP is a micro disease in terms of population effected and often confused with PD. Early clinical trial was extremely small (n=3), but promising. Probably found too many problems recruiting for a CT 2/3 for obvious reasons. RT001 still retains Orphan status for PSP so a physician can still prescribe it.

I would expect CTs focusing on other diseases (INAD and FA) using RT001 to continue since "fast track" was given by the EMA.

sharon

[JBOVERT in reply to sharoncrayn]

WAIT........ DID YOU SAY A PHYSICIAN CAN PERSCRIBE RT001?

[JBOVERT in reply to sharoncrayn]

So Sharon, do you mean I can ask my doctor to give me a scrip for retrotope'sRt1001? Because if that what you meant I am going to call him today

[JBOVERT in reply to JBOVERT]

HI THERE ITS ME AGAIN

Well the news from the clinical administrator for retrotope is that retrotope is an investigational drug and not authorized by the fda so no it cannot be prescribed damn!

unless you know something more I'm going to say I am out of luck!! So if there's any

way that I could get my hands on some of those PUFAS I would like to know...

thank you

best

James

[sharoncrayn in reply to JBOVERT]

"Well the news from the clinical administrator for retrotope is that retrotope (you mean RT001) is an investigational drug and not authorized by the fda so no it cannot be prescribed damn!"

WRONG!

RT001 CAN BE PRESCRIBED IF YOU HAVE BEEN CLINICALLY DIAGNOSED WITH PSP (a rare disease)! IF NOT BY A PHYSICIAN, FORGET IT. THAT WAS MY CONTEXT.

I know "for a fact" the FDA defined RT001 as an "orphan drug" in 2017. In 2020 "I know for a fact" they did so AGAIN for THOSE DIAGNOSED WITH PSP.

LOS ALTOS, Calif., Feb. 18, 2020 (GLOBE NEWSWIRE) -- Retrotope announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development granted orphan drug designation for its chemically-modified polyunsaturated fatty acid drug (RT001) for the treatment of Progressive SupraNuclear Palsy (PSP). Physicians collaborating with Retrotope have previously received approval from the FDA’s Division of Neurology Products to test RT001 in Expanded Access trials of three patients having PSP, an orphan neurodegenerative disorder that causes progressive impairment of balance and walking; impaired eye movement, abnormal muscle rigidity; dysarthria; and dysphagia and eventual death."

A drug can have MULTIPLE orphan designations. Not all insurances cover the full cost of this type of drug so they can be very expensive.

for drugs that receive an orphan drug indication from the U.S. Food and Drug Administration (FDA), companies receive: a 7-year period of market exclusivity, a tax credit of 50 percent of the cost of conducting clinical trials, eligibility for federal research grants, and a waiver of user fees.

sharon

😇

[JBOVERT in reply to sharoncrayn]

THANK YOU SHARON very much! James

[JBOVERT in reply to JBOVERT]

SHARON,now I am trying to get there names of the collaborationists drs (3) and or to see if my dr can be a collaborateur as well..I would appreciate any advice on how Ican get the Rt001