they are going for a new endpoint, survival. Using 28 days as a surrogate.
Not a slam dunk, but it’s worth a shot.
But a positive outcome would require FDA to admit they were somewhat wrong and although there is precedent for this... it’s rare.
FDA had an easy path to approve this week... they chose not to. Some are saying they are playing games... but that is pure speculation and making any assumptions on leniency from the FDA should be done with a lot of care.
This week is a big steer on how the FDA will respond to that Type A meeting.
risk has gone up significantly after this week... debt is huge and without short term cash flow, this can turn very ugly very quickly.
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