Jun. 29 at 10:56 AM
$LRMR The FDA had just held a multidisciplinary pre-BLA meeting and agreed the company could begin its rolling BLA submission.
If FDA believed the safety profile had become fundamentally unacceptable, it would be surprising to see:
* agreement that the package appears capable of supporting review,
* continued willingness to consider accelerated approval,
* agreement to a rolling BLA.
That doesn’t guarantee approval, but it suggests the agency viewed the overall benefit-risk profile as worthy of formal review.
So my suspicion is that the market algorithms and many traders saw:
“Anaphylaxis: 10 of 43”
and sold first.
