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Re: Mfgaumond post# 719

Wednesday, 10/18/2023 2:03:50 PM

Wednesday, October 18, 2023 2:03:50 PM

Post# of 863
I'm confident the product will be approved at some point. The question is when and what amount of dilution happens before then. Management seems confident they won't need another clinical trial but, since the upcoming FDA meeting hasn't happened, it's based on management review of the situation and the briefing docs they assembled.

Is management's confidence an indicator, yes. Might they be surprised by FDA feedback? yes.

I wish the conclusion was obvious, but we're still in a period of high uncertainly.
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