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Re: frrol post# 241907

Thursday, 09/20/2018 1:38:55 PM

Thursday, September 20, 2018 1:38:55 PM

Post# of 403047
Care to speculate, ffrol? (others welcome, also)

What does it mean that BTD for B-OM is still in play?
1. That we have management willing to announced milestone loan agreement based on getting BTD for B-OM by the end of September and then proceeds to sat on application until it was possible that FDA's response would not come in time?
Or
2. That the management filed for BTD well in time and got FDA's no cigar response with FDA's advice how to get the said cigar. Then went to work and refiled, presumably being sane enough to follow FDA's instructions?
Or
3. For some flabbergasting reason the potential BP stalled IPIX filing for BTD until FDA response was likely to be late for milestones?

If you think, as I do, that we have the case number 2, then there are some further speculative statements possible, including this:
Whatever was the FDA's reason for the original rejection it must have been something that the IPIX management thought fixable without additional clinical work.

Highly speculative, of course, but if correct, encouraging.


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