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Biotech / Medical : Momenta Pharmaceuticals Inc. -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (2704)1/7/2011 5:47:43 PM
From: IRWIN JAMES FRANKEL  Respond to of 3027
 
>> I expect this to be a statement that the FDA is "still looking at it." Even if what the FDA actually tells them is that "we're done looking at it until you meet this, that, and the other requirement as measured by thus and so."

You may be right. But I certainly would advise against that if I were representing them. It is too likely to come back at them in some form.

ij



To: tuck who wrote (2704)1/7/2011 11:12:47 PM
From: Jeffry K. Smith  Respond to of 3027
 
"There is no "approvable" event as there is in the NDA process"

As much as I've tried (poorly, I must admit) to keep up with things, I didn't know about the above. Thanks for sharing that valuable information.


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