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Re: Vanilla Fitbit post# 21951

Monday, 09/21/2020 4:29:44 PM

Monday, September 21, 2020 4:29:44 PM

Post# of 44690
Because it could be that they are not yet fully enrolled... That is the danger with EAP designation

Expanded Access Protocol-Many times candidates that fit the trial parameters opt not to go into Clinical trial but can get the drug via EAP. EAP has been known to slow progress of trials being filled with candidates in the past.

With so few locations open in the IV trial for RLF-100 It is likely people have opted for their loved ones on Respirators to have the actual drug as opposed to entering a clinical trial that assigns patients to the drug or to the placebo and no one knows which.

IT's a horrid dilema for researchers ethically and for Family members to have to face. It is the difference in seeing your Loved one on a respirator and wondering if they had RLF-100 or the Placebo...or actually getting the drug through Expanded access Protocol.

This is why EUA- Enhanced Use Authorization is much prefered- The drug can be administered with FDA Authorization and pretty much entirely un hampered... All US hospitals can receive it for patients and it can be administered IMMEDIATELY even if the Study isn't finalized

That will be a major News catalyst, and I suspect we get an immediate $0.20 - $0.70 cents in an hour of trading if not more. Hence the scuttle butt on the forums about EUA today