Protocols are a negotiation and the FDA had previously allowed long-term dosing, 4 dose treatment in the eIND. The company had all the evidence to show the FDA that longer dosing was safe. NP was just in a hurry to do the trial so he "acquiesced." Sorry, it was the company's fault for not being able to make the obvious case if they believed if was the right dosing. But they didn't. It is commonly done by most biopharma companies. But NP caved. Now you blame the FDA -- sorry it was NPs failure.
Rubbish. If the company “believed” in 4 doses they need to show data that supports 4 doses. And that means either from existing trial data or from a separate dosing trial. Neither was provided because Amarex and s a mess and NP chose not to do a dosing trial. Both doors lead to NP failures and hence trial failure. Good he is gone but his stench remains.
News 
Market Data 
Discover 
AI
