Good point - Patience is Key (at every stage)
It is now AVXL that has to make its move and take all the steps (one at a time with no stumbling) to get the data to FDA. What follows next will be More Patience as we wait for FDA to respond.
For those who think that the FDA will take unusually long time to respond, I guess that it also depends on the quality of execution from the companies. Let us hope that the ex FDA guys can get it done (right) in their first attempt. Any delays is only going to prolong the wait.
[As an example, FDA issued a CRL to IBRX on May 9, 2023 for their 'Bladder Cancer Data' BLA Submission. CRL had to do with 3rd party Manufacturing and Process issues. (Trial data is BIC and really good, both statistically and clinically). On Monday this week, IBRX issued a PR; that they submitted the plan to address the issues identified in CRL. (Probably the company did that sometime last week). Today there is a new PR from IBRX stating that FDA has accepted the re-submission and now the FDA has PDUFA date set for April 23, 2024].
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