Met with a current CEO and COB of a NASDAQ listed bio pharma company for several hours today. Both men have extensive bio tech backgrounds and were senior executives at Amgen with extensive experience in oncology. COB is on several pharma company boards. Here is my takeaway regarding CYDY status with FDA.
1. Do not piss off the FDA. They will remember you pissed them off.
2. Do not piss off the FDA. They will remember you pissed them off
3. Hit your trial endpoints, if you do not hit your endpoints you will not get approval.
4. Hit your trial endpoints, if you do not hit your endpoints you will not get approval.
5. FDA will not allow a change in trial protocols during trials. If you start with 2 doses, you will finish with two doses; they will not allow different dosing from Your design, unless you want to start over.
6. Your trial is YOUR trial, even if/when FDA gives input upfront, you own the results. Tough sh$t, that’s the way it works.
7. FDA does move the goalposts. These are mostly “biostatisticians” and they love their numbers even if it does not make sense. For instance they may lump all lung cancers together to test survival rates, even though some mutations may have much shorter expected survival rates.
8. Always take the path of least resistance to get some type of approval so other indications can be used “off label”.
9. Both guys noted that M2M trial never had a chance of approval and was a wasted effort.
Will follow up with outside of US trials, and pros and cons; touched on that previously and it was noted as being a good idea.
My takeaway is that HIV BLA was a real big miss for us and should be pursued with full vigor unless there is more to the story that has not been revealed.
Evaluate CYDY performance relative to above and make the call.
