I think this is the best explanation i can find that outlines the point of difference between
TYPE A
TYPE B
TYPE C
METTINGS WITH THE FDA
Every where else i look it defines a TYPE C meeting as anything other than a TYPE A or B
Yeah about as clear as mud to the layman LOL
However i have managed to find a site that gives more description of the type C application
And i believe it outlines our exact case
See Below
Meeting Types
FDA describes four types of meetings.
Type A
meetings are those that are necessary for an otherwise stalled product development program to proceed or to address an important safety issue. Before submitting a Type A meeting request, requesters should contact the review division or office to discuss the appropriateness of the request.
Type B
meetings include, but are not limited to: Pre-investigational new drug application (pre-IND) meetings; Pre-emergency use authorization meetings; and Pre-new drug application (pre-NDA)/pre-biologics license application (pre-BLA) meetings (21 CFR 312.47).
Type B (EOP) meetings are as follows: Certain end-of-phase 1 meetings (i.e., for products that will be considered for marketing approval under 21 CFR part 312, subpart E, or 21 CFR part 314, subpart H, or similar products) and end-of-phase 2 or pre-phase 3 meetings (21 CFR 312.47).
A Type C meeting is any meeting other than a Type A, Type B, or Type B (EOP)
meeting regarding the development and review of a product, including meetings to facilitate early consultations on the use of a biomarker as a new surrogate endpoint that has never been previously used as the primary basis for product approval in the proposed context of use.
I think the last paragraph in C Explains our situation.
Anyway just a shame Daniel Tippet from @RaceOncology is not on our board, im sure he would have cleared this up in no time for all the ANP HC followers and potential future investors
And as i previously said plenty of time from this initial type c consultation for a Major player to step up to the plate with an offer and input into the proposed FDA trial
SEE HOW WE GO
- Forums
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- US deal for ATL1102
US deal for ATL1102, page-163
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