Sadly what is not understood. The saving 1 life at a time is great--while there is NEVER an approval--thousands DIE
As far as "BTD"--the FDA states --“the criteria for the breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significantly endpoint over available therapy.”
Knowing and submitting data which doesn’t achieve this, proves beyond a reasonable doubt that you and everyone on your team, don’t know the simple requirements for achieving such approval. This is at least the SECOND TIME of submitting BTD for TNBC
___________________________________________________
So are the employees/contractors of CytoDyn guilty of not knowing protocols, requirements and frankly the drugs in which they are competing against in our field??
This is either fraud or just being out of our league ,NOT knowing the basics of industry processes. Either way, “This is OUR business!” You should know everything about requirements, submissions, approval processes and competition. This is what you are hired(and VERY WELL COMPENSATED) to do!
This isn’t a drug issue or side effect issue, results issue, or even R&D issue. This is a mismanagement of filings and trials. MULTIPLE times.
I won't even discuss the BLA --NOW 4 YEARS BEHIND SCHEDULE
Market Data 
Markets 
AI
