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Re: PlentyParanoid post# 250326

Saturday, 12/01/2018 7:32:22 AM

Saturday, December 01, 2018 7:32:22 AM

Post# of 403052
you are to be congratulated on the effort it took to figure this out. The question is what it all means. i still think B OM can get approved but I am very nervous that NOT getting BTD is crucial.

After all B OM is so ideally positioned to get a BTD, no? You have a drug given in the simplest possible fashion to prevent a serious complication of cancer therapy when there is NO good alternative treatment. The setup wass perfect for B OM to get this designation.

Why the failure? That remains the question, and I continue to think it is a very important failure. When will we understand the reason? Was it connected to the term sheet failure? Or is it some technical problem, a minor issue? If so why no clarification from IPIX?

Sorry I still believe it is a big deal and wish we knew more.
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