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Biotech / Medical : Immunomedics (IMMU) - moderated
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To: li3511 who wrote (36037)6/18/2016 1:05:43 PM
From: gaduntz732 Recommendations

Recommended By
bobbseytwins2001
drtom1234

   of 63324
 
Sorry if repetitive, Li.

Some points as I see them, from general info and IMMU PR and analyst reports:

IMMU has meeting minutes from FDA on the AA pathway, which includes enrolling maybe 50+ additional patients, and the ORR rate (confirmed) must meet certain criteria to allow for NDA submission and review.

AA would be granted based on 132's effect on a surrogate endpoint, again ORR (confirmed), which is deemed likely to produce a clinical benefit. It can also be granted if the drug is deemed to have an effect on an intermediate clinical endpoint (PFS), likely to produce a clinical benefit (OS).

AA requires the company perform a larger P3 confirmation study , usually a randomized, controlled study, where the primary endpoints are PFS and OS, in order to achieve full approval. The confirmation study must be enrolling at the time AA is granted.

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