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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Citing numerous concerns about design of the Phase II CENTAUR trial and statistical robustness of the results, agency reviewers question whether a single study provides substantial evidence of efficacy for approval of AMX0035.
Mesoblast’s Cell Therapy For Pediatric GVHD Gets US Panel Green Light Despite FDA's "Substantial Concerns"
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.
Biotech CEOs often express surprise when the FDA rejects their drugs. But collaborative interactions between regulators and drug sponsors count for little if the latter fail to adjust their clinical and regulatory efforts accordingly.