Thursday, November 25, 2021 3:34:12 PM
I'm not saying that this is the case, just that anything is possible when you have a trial that's changing the way trials are to be evaluated.
There is not a doubt in my mind that knowing what they've learned during this trial if they were designing a new trial it would be done very differently. That's fine, but with all they've learned the key right now is gaining an approval based on what they've learned with no further trial required other than to expand the label post approval.
I believe that we all know that companies communicate with the regulators often and rarely report such communication. I just wonder if this trial is so unique that the regulators said, let us help by working with you on understanding the data, if we do so, approval will be accelerated. The only condition would be, the company being in a quiet period until everything was resolved.
Happy Thanksgiving all,
Gary
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