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biosectinvestor

11/06/21 9:56 AM

#415408 RE: MI Dendream #415348

This is a unique trial MID, the regulation in fact validated the trial result. Without it, they can only say what they initially proposed. I believe your premise is an incomplete notion, but I am not here to post what I think on that front as to what the concern is because it is not actually a concern. Just a slow, slow regulator building support for a very major change in methodology and waiting, waiting, waiting to finalize it. If I were a journal, I’d be taking my time as well.