We all heard what Dr Lalezari said we presented to FDA for 4 injections ..
-- Dr Patterson presented to FDA his research from critical patients in Montefiore , where it shows that the sicker is the patient the higher is CCL5 (Rantes ), and when patients getting better Rantes going down, and in most of this severe/critical patients , Rantes was still very high at 14 days , so why will anyone inject leronlimab only at 0 and 7 day, when at 14 days medicine was still needed.
And Drs , Harish , and Yang and Lalezari presented their experience in treating EINDs patients in covid ..
Nothing else was needed for FDA to approve what company was asking ,
4 doses...but they didn't.
FDA allowed patients with HIV to use leronlimab every week for years , without one serious side effect ..
FDA evaluated studies in HIV for efficacy and safety for 350 , 525 and 700 mg ,
in 24 weeks study so safety can be evaluated , FDA said..., they didn't find any safety problems so they told cydy to use 700 mg in BLA application...,
Now they asked for aggregated safety data so they will have it..but this change nothing..
And they allowed over 100 patients with severe/critical covid to use leronlimab as EINDs, and they were afraid of 2 more doses in our CD12 ?? not possible no matter what the hit letter said..
Why FDA wrote these hit letters I don't know..I really don't know what they want to prove by it , except to damage us in Philippine and India ..imo..
And I also don't know why FDA approved few months ago Biogen drug for Alz..
During study results were terrible.
-- there was no clinical significance .
-- no endpoint met ,
-- no p-value.
Up to 30% patients as a side effects developing cerebral edema and hemorrhage.
And look that at least one patient died already from these side effects after approval..what happen to safety profile here ????
If only anyone will explain how FDA is working , some things we know ,
they catering to BP , BP paying about 50% of their expenses , BP giving them very lucrative jobs when they leaving FDA..
Any other benefits , I don't know , but those are enough already imo.
All IMO.
GLTA longs.
