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Re: Tiger Money post# 608

Friday, 11/26/2021 11:53:01 AM

Friday, November 26, 2021 11:53:01 AM

Post# of 1101
Dr. J can present more data, doctors, survivor testimonials etc...
Type A Meetings are for:

Immediately necessary for an otherwise stalled drug development program to proceed. Type A meetings may include:

Dispute resolution meetings as described in the Code of Federal Regulations (CFR), and in the Guidance for Industry Formal Dispute Resolution: Appeals Above the Division Level
Meetings to discuss clinical holds in which development is stalled and a new path forward should be discussed
Special protocol assessment meetings that are requested by sponsors or applicants after receipt of FDA evaluation of protocols under the special protocol assessment procedures
Post-action meetings requested by the sponsor within 3 months after an FDA regulatory action other than an approval
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