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Re: H2R post# 42241

Thursday, 08/18/2022 11:38:58 AM

Thursday, August 18, 2022 11:38:58 AM

Post# of 43784
H2R, thanks for posting that chart. I agree that this rapid resubmission is indicative of the trial results finally being close to approval for future FDA submission. That was my take-away, at least, and my hope - I've been burned a few times by CVM over the past decade, so nothing would surprise me here, lol.

Despite all of the noise surrounding the trial results, I can't imagine how complex the trial data must be, given length of run-time, number of patients involved, and the number of sites and countries where the trial was conducted. From this perspective, I think that CT sending the results back for more editing several times is reasonable, if frustrating. I'm sure there are MANY T's to cross and I's to dot. I try to keep this in mind while I wait for things to start moving a little faster...

Best of luck to you, as well.
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