Not saying there is, but to beat them, the rules have to be understood and played to the “ letter of the law”, with NO Deviations.
Nader NEVER did that, even though the HIV BLA was incomplete, it was essentially doomed from the start because Nader had an endpoint for the COMBO TRIAL and was trying to do an end run around the FDA for MONO( read massive short cut).
The smart play was to get and approval for anything and then work off of that for other indications.
WHY WAS THAT APPROACH NEVER USED FOR LL? Was it pure incompetence or did he know it would never pass a trial?
Shotgun, constant pivot… Combo to mono, to CoVID, to cancer , back to HIV, to NASH. A small company with limited resources cannot function without focus.
I said that years ago and here we are dead in the water with no money, a low stock price and fundamental failures at every level, with tens of millions due in days and weeks.
Naders approach does not work with bureaucrats …you have to use the “Thank you sir may I have another “ approach. Nader’s smartest guy in the room personality would not allow that.
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