I get why you think this would be a good move however I tend to go the other way.
The FDA sent a very clear message to the industry when they issued the CRL and then they reinforced that message by stopping the COVID ARDS program.
Potancy assay must be up to the task regardless of results.
For industry to progress onto pivotal trials with out the above been addressed would give FDA the wrong impression. First would be " they dont care what we the FDA think" result would be " We the FDA will show them"
Then we would also give the FDA the opportunity to defer what is a pivotal deccision for not just MSB but the industry. " Looks like MSB is moveing on, the industry will follow, all good , we can come back in a few years and have a look."
2023 The Final Countdown, page-1407
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