Two points worth discussing.
1. Why did MSB choose to take the path of a Formal Meeting, in particular a Type A meeting? Was it just to seek expedited approval?
2. If the request for a type A meeting is rejected, what is plan b?
A company would normally, after receiving a CRL, have informal discussions with the FDA before submitting a response to the CRL --
"FDA recently published MAPP 6020.4 Rev.2, titled,“Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Complete Response Letters” This revision is an update connected with some of the commitments required of FDA commensurate with the most recent PDUFA renewal. It goes toward the answer to the main burning question connected to every application under review: WHEN?
The process described in the MAPP is pretty straightforward:
- Applicant submits a response to a Complete Response Letter (CRL)
- FDA determines whether or not the response is complete and responds in a letter to the applicant within 30 calendar days
- If FDA determines the response is NOT complete CDER so informs the applicant and the review clock does not start until a complete response is received.
- If FDA determines that the response is complete, it will be classified as Class 1 or Class 2"
from:
https://camargopharma.com/resources/blog/mapping-out-the-timing-of-a-complete-response-submission/A type A meeting has the advantage, if granted, of having the FDA superiors of the person who made the decision present.
"III. MEETING TYPES2
There are three types of meetings that occur between sponsors or applicants and FDA staff: Type
A, Type B, and Type C. Each meeting type is subject to different procedures, as described
below.
A. Type A Meeting
A Type A meeting is a meeting needed to help an otherwise stalled product development
program proceed. Examples of a Type A meeting include:
• Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in
the guidance for industry Formal Dispute Resolution: Appeals Above the Division Level3
• Meetings to discuss clinical holds in which a response to hold issues has been submitted,
but the FDA and the sponsor or applicant agree that the 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
as described in the guidance for industry Special Protocol Assessment
2 The meeting types and goal dates were negotiated under PDUFA and apply to formal meetings between FDA staff
and sponsors or applicants of PDUFA products; they do not apply to meetings with CDER Office of Generic Drugs
(OGD), CDER Office of Compliance, or CDER Division of Drug Marketing, Advertising, and Communications
(DDMAC). However, OGD will attempt to meet the time frames set out under Type A and Type C meetings, and
CDER Office of Compliance and DDMAC will apply GMMPs to the extent possible with the exception of the
specific meeting types and goal dates."
see:
https://www.fda.gov/media/72253/download
(20min delay)