>> since the bla is open and the fda has already reviewed all the prior information neop will only have to submit the new data from the new trial and the fda will be able to respond in probably 3 to 6 months. So the fact is that the open bla saves neop time and money because they aren't starting from scratch but the fda time because they aren't reviewing an entire package. You got this wrong just like everyone else. the story is totally misunderstood because no one covers it. <<
You say the FDA review will last 3-6 months. Well, is it 3 or is it 6? If it’s 6 months, that’s no different than the FDA’s evaluation time for a de novo priority review.
Even in the (unlikely, IMHO) event that the FDA review takes only 3 months, that barely makes a difference in the overall scheme of things. The major critical-path work –the new pivotal trial and the CMC submission— are going to be the same as for a de novo BLA submission.
I stand by the assertion that the “open BLA” is mostly hype and is essentially meaningless from an investment standpoint.
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