RE:ISPENAs far I know they plan to arrange Type A meeting but they have not shared a date. We also do not know what they are planning to accomplish at this meeting. There is a lot to be sorted out, how does Ipsen view the latest results, they are not obligated to stick around; if they do I think that's a great indicator. If they do I don't see why they wouldn't just buy TST
Here are the Type A meeting examples.
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:
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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
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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
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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
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 the appropriateness 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.