Time to dust off the chicken salt.. and get the next bag ready.
GvHD to resubmit ... or not to resubmit... that is the question.
MSB released a statement saying that they had been in regular contact with the FDA during the resubmission process. We know from FDA guidelines that each CRL item is not only specifically described in the CRL... but FDA also gives guidance to companies as to ' what' they think the company might do to move the BLA to an approveable state. We also know that MSB said in the previous operational update that it believed it had addressed all items in the CRL and was ready to resubmit the BLA in the current quarter.
MSB then updated its application file with substantial new information that it believes addresses items raised in the CRL. Remember that MSB's application is a modular type, and they discuss both CMC potency and outcomes efficacy, so more than likely they have updated multiple modules.
Did the FDA tell them... as part of the process you need to fix these modules? According to the guidelines FDA is supposed to give resolution like advice, so if it was the case, then it should have occurred.
What next? Well there is mass conjecture on this forum over what was actually submitted, and what the timeline is.
I think if MSB has not received feedback by 2nd November, then its not a full resubmission... but what is it exactly ? Are they simply re-starting their BLA? Was that the agreement ?
Below are the guidelines as to what MSB must do in response, as you can see no-where does it talk about updating IND files.... however, how else is a company supposed to respond to deficiencies in the IND file except updating it ?
Guidelines below Applicant actions. After receiving a complete response letter, the applicant must take one of following actions1) Resubmission. Resubmit the application or abbreviated application, addressing all deficiencies identified in the complete response letter.(i) A resubmission of an application or efficacy supplement that FDA classifies as a Class 1 resubmission constitutes an agreement by the applicant to start a new 2-month review cycle beginning on the date FDA receives the resubmission.(ii) A resubmission of an application or efficacy supplement that FDA classifies as a Class 2 resubmission constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.(iii) A resubmission of an NDA supplement other than an efficacy supplement constitutes an agreement by the applicant to start a new review cycle the same length as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial supplement), beginning on the date FDA receives the resubmission.(iv) A major resubmission of an abbreviated application constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.(v) A minor resubmission of an abbreviated application constitutes an agreement by the applicant to start a new review cycle beginning on the date FDA receives the resubmission.
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1) Resubmission. Resubmit the application or abbreviated application, addressing all deficiencies identified in the complete response letter.(i) A resubmission of an application or efficacy supplement that FDA classifies as a Class 1 resubmission constitutes an agreement by the applicant to start a new 2-month review cycle beginning on the date FDA receives the resubmission.(ii) A resubmission of an application or efficacy supplement that FDA classifies as a Class 2 resubmission constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.(iii) A resubmission of an NDA supplement other than an efficacy supplement constitutes an agreement by the applicant to start a new review cycle the same length as the initial review cycle for the supplement (excluding any extension due to a major amendment of the initial supplement), beginning on the date FDA receives the resubmission.(iv) A major resubmission of an abbreviated application constitutes an agreement by the applicant to start a new 6-month review cycle beginning on the date FDA receives the resubmission.(v) A minor resubmission of an abbreviated application constitutes an agreement by the applicant to start a new review cycle beginning on the date FDA receives the resubmission.
(20min delay)