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georgejjl

04/28/21 3:39 PM

#357339 RE: sox040713 #357338

Maybe IPIX should expand trials into India

India Covid: Hospitals overwhelmed as deaths pass 200,000

https://www.bbc.com/news/world-asia-56919924

Good luck and GOD bless,

petemantx

04/28/21 4:19 PM

#357342 RE: sox040713 #357338

What possible blame can you find with IPIX for the slower than expected enrollment? Once the trial parameters and sites are fixed, things are completely out of IPIX hands.

How long did it take for FDA to approve 3 to 5 day dosing? For 30 people, and only 15 on Brilacidin, should have taken within one day in my book but IMO and from uncorroborated whispers it may have taken a number of weeks. So who is to blame for that, IPIX? I think not.

Maybe parameters imposed by FDA as to patients were overly restrictive, sites had problems of one sort or another, a whole assortment of possible delay reasons. One major problem in Russian trials is the FDA saying every little last piece of equipment, whether relevant or not, has to come from specific suppliers and at times Russia has problems acquiring them. This is just another example I am giving, not saying it is the actual reason.

So going to IPIX for the blame IMO is pure crapola.

I am disappointed in only being at, or near, 50% enrollment but not disappointed in IPIX, mgt, or Brilacidin in any way. Angry at the "system" and mainly at why the RBLs findings seem to be not worth a damn to this point to the FDA (at least in terms of pushing B as quickly as possible to dying patients. At the worst, if they allowed a fast EUA it might at most (and extremely unlikely per RBL and past Cinical Trial results) endanger a handful of patients but it would also provide an opportunity to save many tens of thousands).