Cytodyn Inc (CYDY)

[misiu143]

Well , I do not agree , when FDA see drug saving lives and not an experience management , I will think they give them proper advise so drug is approve asap and helping people. They are here to help us when we sick..

Actually I am so upset about all this , that I just emailed all what i am thinking to Dr Woodcock.

--I asked that they send now another letter about leronlimab to correct all the miss-information they put in this " HIT " they send few days ago.

--I posted that our NEWS2 , very important endpoints are Statistically Significant at 14 days ..

-- I gave her all improvement in mortality even with the 2 doses they , FDA restricted this company in CD12 ,
I gave her ALL numbers from 7 , 14 , 21 and 28 days,
and I asked if even with 2 doses , 31% improvement in mortality at 28 days , above SOC drugs don't deserve EUA ,

But one day less in hospitalization with baricitinib does ..

--I asked is it fair to give to some companies protocol when they may " PICK" during ongoing study and just at the end choose proper endpoint , all this without penalties ,
I asked her if FDA consider this as a fair dealing with different companies .

--I told her that the Hit letter FDA send few days ago , affecting now lives even more , since doctors who know nothing about leronlimab , refusing to order it for their patients ..

Well, I don't expect answer , but what FDA is doing is so terrible , at least I feel better , I did what I should.


All IMO.