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Tuesday, November 20, 2018 5:26:12 PM
The 60 days only means that the FDA has most likely made a decision on B-OM BTD approval by now. I believe the EOP mtg in Dec points highly for a positive response, but that is just a gut WAG.
However, it has no bearing whatsoever as to when their decision is to be made public as it has been discussed that the FDA only releases BTD results semi-annually and the company does not have to release the information if it has some bearing on current negotiations.
Thus, it is up to IPIX mgt as to when they announce BTD results. They may decide the proper time for announcement is any time between now to the end of December (thus prior to the FDA release of information)if they intend to release such information at all.
Nobody has a clue what date has been determined for the release of the BTD so all guesses are worth the same - zilch.
I thus will take no negative connotation as to whether B-OM was approved or disapproved for BTD until after the EOP mtg in mid-Dec with the FDA.
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