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Biotech / Medical : Immunomedics (IMMU) - moderated

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erippetoe
To: stockdoc77 who wrote (63232)8/16/2025 12:22:20 AM
From: ghettogoulash1 Recommendation  Read Replies (1) of 63276
 
SRPT: this rally might have legs. FDA just granted full approval to Precigen’s viral vector-based gene therapy today. In fact, the BLA filed in December was seeking only Accelerated Approval. “Randomized trials are not always needed to approve medical products and this approval is proof of that philosophy,” Vinay Prasad, M.D., the director of the FDA’s Center for Biologics Evaluation and Research, said in a release. “The FDA will always demand the correct clinical study for the specific medical product and disease. Our requirements for products given to tens of millions of healthy people will be different than products given to at most hundreds or thousands of patients with unique diseases.”

All we want is a level playing field, A-hole. You too, Makary.

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