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awayfromhome

08/15/20 10:30 AM

#106328 RE: Scooter McCabe #106315


4. Committed to resubmitting BLA. On track for that with seeking the Type A meeting with the FDA. Who would submit another FDA before seeking guidance? Answer is no one.
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Which begs this question: Did the FDA previous guidance for BLA include the request for those bits of information which were not included in our application and allowed the FDA to give us a Refusal to File letter which will cost us another year of delay?

The oNiOnHEAd

08/16/20 2:08 AM

#106515 RE: Scooter McCabe #106315

Scooter, You're positive review of the 10K gives me shivers!

The oNiOnHEAd

08/16/20 2:08 AM

#106516 RE: Scooter McCabe #106315

Scooter, You're positive review of the 10K sent a shiver down my spine!