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Posted On: 09/21/2023 2:57:10 PM
Post# of 148902
Re: generactor #137366
There are those who would pin it all on Nader, and excuse Kazempour by saying that he submitted the BLA only because Nader told him to. I.e., Kaz was just doing what Nader told him to.
Except. Note this from the first paragraph:
Sure, Nader told Kaz to submit anyway. But what was Kaz doing for those two years, besides failing to include data the FDA had been asking for? Nader must have been pretty frustrated. And we, meanwhile, wonder why Kaz and Amarex never included material the FDA had been asking for during two years. A period in which they were paid scores of millions of dollars.
All of which, and more, we should get back from Amarex.
Except. Note this from the first paragraph:
Quote:
[the BLA] was missing key clinical data that the FDA had been telling the company it must include in its BLA submission for nearly two years.
Sure, Nader told Kaz to submit anyway. But what was Kaz doing for those two years, besides failing to include data the FDA had been asking for? Nader must have been pretty frustrated. And we, meanwhile, wonder why Kaz and Amarex never included material the FDA had been asking for during two years. A period in which they were paid scores of millions of dollars.
All of which, and more, we should get back from Amarex.
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