Does anyone have Nader’s full email to Amarex? I’d love to see that as well as the antecedent Amarex communication. We are reacting to what amounts to a snippet of a sound bite. Without context, I see four scenarios that might explain Nader’s email. First the 13d scenario, Nader was being pressed for months to announce the BLA. He got mad and even tho he knew the shortcomings of the BLA submission, he wanted the deficient application to go forward. As I said before without the CYA documentation from Amarex, this seems a low probability.
I think more probably, he was told of the deficiencies but was given the impression that the deficiencies could be cured in an amended submission. If I remember correctly the BLA was originally submitted and then about 4 weeks later an amended version was submitted to the FDA. Obviously the resubmission-was also deficient. I think this has a much greater possibility of being applicable.
Another possibility could be that Amarex downplayed or did not fully convey the extent of the deficiencies. Based on this, Nader believed correction of the deficiencies would be easy. A very good possibility, in my opinion. Of course, there is the possibility that Amarex did not understand the holes in its presentation because of staffing changes, shortages,etc.
Finally that Nader understood that the shortage was an 8 by 10 glossy of Charlie Sheehan, and told them submit. So until Amarex provides all of the context to their allegations, everything is conjecture and I have wasted everybody’s time. My apologies. I rarely comment this frequently