It seems very obvious that many here screeching daily never actually read, and most importantly UNDERSTOOD what the PR actually stated...............pay special attention to the WORDS IN RED.
"After a further in-depth review and analysis of the FDA recommendations with members of the Company’s clinical trial team, including its statistician, regulatory affairs, medical affairs, and clinical research advisors, the Company has decided that in the best interest of the Study to preserve and not compromise the integrity of the Study and keep the blinded data intact to support a potential FDA approval in the future. As such, the Company will remain with the current Study protocol’s primary endpoint of proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization. Although the Study was originally designed for a ‘hospitalization or death’ primary endpoint, and it completed enrollment of almost three-quarters of the Study’s recruitment goal and recorded specific clinical symptoms (i.e. cough, fever, heart rate, and oxygen saturation), the Study was not designed to take into account all of the symptom assessments and supporting data outlined in the FDA guidelines to warrant a primary symptom-based endpoint for COVID-19 studies."
According to the RVV team (NOT ME), the reason they decided against going with the FDA's ep parameters is solely because the original trial was NOT DESIGNED to collect the data the FDA was requesting.
Essentially what would have happened if the rvv team had accepted those ep parameters and the trial data unblinded and presented for review, the ep change submission would have FAILED and as such been rejected by the FDA since it could never satisfy the standards set, ie you cant pass an English test by answering in Greek!!!!
I can only imagine the Nuclear Meltdown that would have occurred if they had decided to ignore the data deficiencies and knowingly made a submission that was flawed, inadequate and thus doomed to fail.
I am simply restating the official position of the company from the PR, not my own, but if you or any of the other banshees have evidence that their claim is untrue do feel free to present same instead of posting incoherent nonsense.
I have already indicated that the handling of this whole ep process has been, IMO, inept so I am by no means an apologist for those responsible for this farcical waste of 6-8 valuable months.
Now, TRY AGAIN!!!
