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29.0¢ botanix pharmaceuticals ltd

here's hoping the FDA human factors team set strict...

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Chebbbit

141 Posts.

27

13/05/24

09:09

Post #: 73790271
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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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here's hoping the FDA human factors team set strict guidelines for what constitutes a complete trial and advised along the way.
they'd surely have a solid framework to inform companies of requirements so each HF study comes back formatted correctly and answering the same questions. thank god it was just the one thing that needed correcting

BOT Price at posting: 27.5¢ Sentiment: Hold Disclosure: Held
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