If the resubmission is incomplete:
1. Ensure the designation in the regulatory system is corrected to
“Incomplete Response to CR letter” if the review team confirms that the
submission did not address all issues identified in the CR letter
CRL one questioned multiple issues including efficacy
CRL questioned ,imo, two issues- potency assay of trial product- potency of product to be sold if marketing approval given.
FDA saying go ahead and refile , one could consider that issues identified had been addressed-
I like our chances
Reg- been wrong twice
If the resubmission is incomplete:1. Ensure the designation in...
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