I wasn't necessarily "looking for reasons why FDA might have rejected the initial BTD application and we are now in refiled stage". My questions were regarding the BTD issues regardless of whether the FDA is reviewing the first, second or third submission.
That said, we once again have heard from some that a given result to some specific effort is a shoo-in, a lock. Seems to me that if that was true the BTD would have already been shooed in. I suppose the Agreement terms at the end of June could have been established without the BTD submission being filed but there doesn't seem to be any good reason for that to have happened. The only "news" about B-OM since the 6/28 PR agreement announcement was a July 17th PR announcing a sachet mfg contract...and you don't think that that's an issue.
Again, my questions reflected no presuppositions about the "stage" of the submission. IF the Agreement was made in a good faith attempt to secure some cash and IF the BTD was the shoo-in that some think it was, then there most be some reason, hopefully a good one, for the delay. My questions were an attempt to get your help in finding out what it was (or is).
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