Sunday, July 17, 2022 1:36:49 PM
I do hold it against management that they were not working on this trial design even prior to the CRL notice. They knew it was an ifffy decision back then. And even if they were approved then a P4 such as this would have been useful to expand the label.
Anyway, that is water under the bridge.
I have to assume the odds of the new trial being a success are good. They have the data in hand to pick the patients and comparison to trial. In this space that is fine because all they are trying to be is just another weapon in the arsenal (they do not need to be the best).
This will take time though. I would have late 2024 as reasonable for results based on the previous oral trial. Supposedly they have enough cash to get into 2024. Sounds like one more raise is going to be needed.
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