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PennyWorld

11/26/21 11:50 AM

#609 RE: Tiger Money #608

What is a Type A FDA meeting?
Type A meetings are necessary for proceeding with a stalled product development program or addressing an important related safety issue, according to the FDA. ... Following a Type A meeting, companies typically take the feedback from the meeting and use it to address the issues impeding drug development or approval.

Per NRXP following EUA rejection....
We will work actively with the FDA to deliver the data it has requested so that we may offer those patients another chance at life, and have asked the FDA for a Type A meeting that will include the experience of physicians who have witnessed the effects of our medicine firsthand and the experience of patients who are alive today because they were given one last chance at life.

threebabiesbusy

11/26/21 11:50 AM

#610 RE: Tiger Money #608

Will we see upward movement in RLFTF?

nothing-but-patience

11/26/21 11:53 AM

#612 RE: Tiger Money #608

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