Stock Watch: Positive Trial Announcements Need A Pinch Of Salt
Only After The FDA Has Had Its Say Can Celebrations Begin
The announcement of a positive clinical trial and an intention to proceed to a regulatory submission are causes for a company’s investors to rejoice. Sometimes that can be premature.
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Oncologic Drugs Advisory Committee votes 8-2 that data support efficacy of the product, which could be the first mesenchymal stem cell product to clear the agency. FDA's concerns include reliance on a pivotal Phase III single-arm study.
Another blow-out quarter from Pfizer provided the impetus for an acquisition. But the history of recent commercial-stage biotech transactions and the risky nature of all early-stage companies suggest that the floodgates will not burst open.