RE:RE:how long is in FDA "FAST TRACK" APPROVAL goldyhawk wrote: EDT's breakthrough designation probably means quicker FDA attention and/or approval
Anyone know what time period that might require ?
The Trial end is mainly a function of enrollment. BTD doesn't normally speed up enrollment, although it's likely that it may be used as a tool to convince patients (or their families) to join the Trial. It will also speed up snags and back and forth discussions (during Interiim Reviews, results analysis, protocol amendments, etc.)
While the Company will always deny it, I think the BTD and with results "greatly exceeding expectations" , to me there is a good chance that Baxter will have seen enough at 90 patients (Interim Review). Perhaps even the FDA will agree. There may even be statistical "confirmation" at 90 patients...if the results are that good.
They may also be influenced by other RWE and perhaps Baxter will like EDEN results - with its implications for label expansion. (hint: Label expansion = vastly more revenue - so there are some benefits to a delay)
Does Baxter need to see 90% certaintly? 95% ? or 100%?
So IMO, there a possibility to have this wrapped up by the end of 2022
I hope that Seto's, and tapped Board members are good poker players....that's what it'll take to get full value and early. Or will he take advantage of the unknown state of this stock?
MM