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38.5¢ botanix pharmaceuticals ltd

I have thought of that kind of left-field issue also. But EVEN...

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JeffN

543 Posts.

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13/05/24

08:34

Post #: 73789688
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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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I have thought of that kind of left-field issue also. But EVEN IF that happens its just back to the drawing board for 6 months. Not a great outcome but not a death knell either.

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