when a drug is in phase 3 and gets their data that have to file a bla that includes all kind of information from all their trials and preclincal information. from the time that information is submitted the fda takes a year to 18 months to review that whole package.
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.
This is like genaera was when I was holding that at 30 cents, only this is closer to market.
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