I posted this on the thread regarding CRLs written by Husch Blackwell LLP.
https://mondaq.com/pdf/clients/371622.pdf
On page 8 under “Responding to a Complete Response Letter,” you can respond to the FDA in 3 ways. Resubmit an application, withdraw an application or request a hearing. The hearing described does not seem to be the same as a “type A” meeting. Does this mean if MSB’s request for a type A meeting is rejected or the accelerated approval is rejected, they can fall back on one of the 3 response options listed above.
It doesn’t seem that requesting a type A meeting falls under one of the listed responses to a CRL. I’m assuming MSB will respond to the CRL as well as requesting the type A meeting?
MSB to dispute FDA finding in Type A meeting, page-397
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