Based on my previous post here (https://hotcopper.com.au/threads/msb-to-dispute-fda-finding-in-type-a-meeting.5663639/page-173?post_id=47825421) it shows priority review and accelerated approval are two different approval processes and you cannot get conditional approval under the priority review, but only through accelerated approval. So I doubt the FDA would've considered conditional approval as part of the priority review, hence the CRL. I wonder if this is a deliberate strategy by the FDA.
I'm trying to work out how the Type A meeting is likely to take place and how accelerated approval is likely to be granted. Below is some information regarding details for a Type A meeting, but I still think we need to figure out the process that needs to be followed for accelerated approval i.e. can the FDA consider accelerated approval as part of a Type A meeting?
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 afterreceipt of FDA evaluation of protocols under the special protocol assessment proceduresas described in the guidance for industry Special Protocol Assessment If sponsors or applicants are considering a request for a Type A meeting, before submitting the request they should contact the review division in either CBER or CDER to discuss theappropriateness of the request. Type A meetings should be scheduled to occur within 30 days of FDA receipt of a written meeting request. If a sponsor or applicant requests a meeting date that is beyond 30 days from the date of the request receipt, we will work with the sponsor or applicant to determine the earliest agreeable date.
MEETING REQUESTS BY SPONSORS OR APPLICANTS
The meeting request should include the following information: 1.Product name. 2.Application number (if applicable). 3.Chemical name and structure. 4.Proposed indication(s) or context of product development. 5.Type of meeting being requested (i.e., Type A, Type B, or Type C). If a Type A meeting is requested, the rationale should be included. 6.A brief statement of the purpose and objectives of the meeting. This statement should include a brief background of the issues underlying the agenda. It also can include a brief summary of completed or planned studies and clinical trials or data that the sponsor or applicant intends to discuss at the meeting, the general nature of the critical questions to be asked, and where the meeting fits in overall development plans. Although the statement should not provide detailed documentation of trial designs or completed studies and clinical trials, it should provide enough information to facilitate understanding of the issues, such as a small table that summarizes major results. 7.A proposed agenda. 8.A list of proposed questions, grouped by discipline. For each question there should be a brief explanation of the context and purpose of the question. Contains Nonbinding Recommendations5 9.A list of all individuals with their titles and affiliations who will attend the requested meeting from the sponsor’s or applicant’s organization and consultants. 10.A list of FDA staff, if known, or disciplines asked to participate in the requested meeting. 11.Suggested dates and times (e.g., morning or afternoon) for the meeting that are within or beyond the appropriate time frame of the meeting type being requested. 12.The format of the meeting (i.e., face to face, teleconference, or videoconference).
The sponsor or applicant, when writing a meeting request that contains the above components (items 1-12), should define the specific areas of input needed from CBER or CDER. A well-written meeting request that uses the above components as a guide can help the FDA understand and assess the utility and timing of the meeting related to product development or review. Although CBER or CDER will determine the final meeting type (i.e., Type A, Type B, or Type C), the sponsor or applicant should provide its meeting type assessment as it relates to the product’s development. The list of sponsor or applicant attendees and the list of requested FDA attendees can be useful in providing or preparing for the input needed at the meeting. However,during the time between the request and the meeting, the projected attendees can change. Therefore, an updated list of attendees with their titles and affiliations should be included in the meeting package and a final list provided to the appropriate FDA contact before the meeting (see section VII.C.). The objectives and agenda provide overall context for the meeting topics, but it is the list of questions that is most critical to understanding the kind of information or input needed by the sponsor or applicant and to focus the discussion, should the meeting be granted. Each question should be precise and include a brief explanation of the context and purpose of the question.
V. ASSESSING MEETING REQUESTS The CBER or CDER division director or designee who receives a meeting request will determine whether to hold the meeting and will respond to the sponsor or applicant by granting or denyingthe meeting within 14 days of receipt of the request for Type A meetings and within 21 days for Type B and Type C meetings.
A. Meeting Denied If a meeting request is denied, notification to the sponsor or applicant will include an explanation of the reason for the denial. Denials will be based on a substantive reason, not merely on the absence of a minor element of the meeting request or meeting package items. For example, a meeting can be denied because it is premature for the stage of product development. A subsequent request to schedule the meeting will be considered as a new request (i.e., a request that merits a new set of time frames as described in section III).
B. Meeting Granted If a meeting request is granted, CBER or CDER will notify the sponsor or applicant of the decision and schedule the meeting by determining the meeting type, date, time, length, place, and expected FDA participants. All of the scheduling information will be forwarded to the sponsor or applicant as soon as possible following the granting notification, and within the specified PDUFA timelines
MSB Price at posting:
$3.19 Sentiment: Buy Disclosure: Held
(20min delay)