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forumreader35

10/09/20 1:35 PM

#315960 RE: ahp123 #315942

I agree here also. Usually when info is submitted, if no comment within 30 days and that time lapses you know it is okay to proceed. You can ask specific questions and request a response, but outside SPA it is more of "okay to proceed". SPA is different and more of guarantee in a way, if we do/show X, we can get approved. Happens with rare disease (although could be under orphan instead) or great unmet need.