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28.0¢ botanix pharmaceuticals ltd

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13/05/24

11:05

Post #: 73793416
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Originally posted by dachopper: ↑

Could turn out to be a brilliant decision for the both of us and everyone else then .

The CRL might be re-issued assuming the label is correct, in light of new information.

The only new information is the results of the HF trial. Now we expect this to be straight forward given the result was 100% used the product correctly, however FDA might take issue with the number or the way the HF trial was conducted. Just putting it out there, it could happen. Its extremely unlikely IMO the trial would have had to been conducted by amateurs for this scale of error , but possible never the less. That is my only doubt, and its balanced against the large number of treatments the team have successfully bought to market, makes me think they must know what they are doing.

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Suggest people have a read of this and digest it......

https://pink.citeline.com/PS147548/US-FDAs-Use-Of-CRLs-Hit-A-High-Note-In-2022-One-Third-Of-Novel-Agent-Decisions-Were-Not-Approvals

The 2022 CRLs for novel agents were almost split between letters citing clinical concerns and letters citing quality issues (11 CRLs focused on clinical topics, 8 focused on quality and one is undisclosed). However, the road ahead appears rockier for the clinical cohort than the quality CRLs.

BOT Price at posting: 29.0¢ Sentiment: None Disclosure: Held
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