I have been regulated by the FDA for close to 30 years and I can assure you nothing has changed the onus is always on the company to meet with them tell them what they are seeking to accomplish and then validate it through the science.
Nobody has been more optimistic on the stock than I have, close to seven years I’ve been invested in it and we still don’t have FDA approval on our primary indication that started it all.
Chasing one squirrel after the next is a distraction and disruption to key resources both financial and Human and precludes us from getting the job done and getting any indication over the goal line.
we need revenue on any indication and HIV is still the best chance at achieving that because we passed the clinical trials and proved statistical significance. The heavy lifting has been done we need a leader to get it over the goal line.
Do no harm. By refusing Dr Lalazeri's request for shot #3&4 the FDA folks put those folks in severe jeopardy - how many did they kill ? So much for >> do no harm.