Will AOH1996 get FDA acceleration? | Manifold

Will AOH1996 get FDA acceleration?

Basic

3

Ṁ27

2025

50%

chance

1D

1W

1M

ALL

The FDA has 4 standard acceleration programs

Priority Review
Breakthrough Therapy
Accelerated Approval
Fast Track

If any trial for the drug AOH1996 is put on one or more of these tracks the market will resolve yes.

The drug must actually be accepted into one of these accelerated programs, if e.g. the drug company doesn't make the necessary request, the market will resolve no even if it "would have" been approved by the FDA.

Acceptance into these programs is all reported unambiguously by the FDA, e.g.

https://www.fda.gov/drugs/nda-and-bla-approvals/breakthrough-therapy-approvals FDA reports will be the truth source.

Setting the close date 2 years out, as that agrees with the approval timeline market. Will extend iff there is material pending progress, e.g. company has filed paperwork for one of the above.

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Related questions

Will AOH1996 be FDA approved before 2040?

Will AOH1996 advance past Phase II trials by the end of 2027?

Will AOH1996 succeed in Phase I trial?

When will the "100% effective against solid tumors" cancer pill AOH1996 be approved by the FDA?

Greater than 1200 AI medical devices cleared by the FDA by the end of 2024?

Will the pre-clinical results on the cancer drug AOH1996 be broadly confirmed by independent team(s)?

Will Epi-On CXL receive FDA approval by 2025

Will an AI-designed drug get FDA approval by the end of 2025?

When will we confidently know whether AOH1996 is effective?

Will a drug to be used by most healthy adults be approved by 2043 year end?

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