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Biotech / Medical : Immunomedics (IMMU) - moderated -- Ignore unavailable to you. Want to Upgrade?

To: KeeptheFaith who wrote (49576)1/22/2019 12:36:36 PM
From: stockdoc7715 Recommendations

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  Respond to of 63320
 
My understanding is that the FDA does a full review of the application and lists any deficiencies in the CRL. As they did not ask for additional clinical data I conclude that they are satisfied on the efficacy of 132. I don't think the FDA would hide the ball or move the goalposts with regards to something this important.



To: KeeptheFaith who wrote (49576)1/22/2019 12:42:47 PM
From: kdd999  Respond to of 63320
 
In its procedures, fda states that if items in crl being addressed for one thing lead to dubsequent questions about other data they can open new issues. Like the fbi. They can go on forever. But probably wont unless lets say procedural or equipment problems might invalidate observed effects of the drug. Ie, you tested, but not sure what you actually gave patients, maybe a contaminent is what cured them.

Not likely with stuff in question in our case.


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