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Objective Views on Lead product: BTX 1503 (Acne), page-8

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Justanovice

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06/07/20

11:33

Post #: 45665418
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Originally posted by T.E.P.: ↑

Botanix is developing BTX 1503 as a novel treatment for moderate to severe acne.

Phase 1:
Botanix successfully completed a Phase 1b study of BTX 1503 during 1Q CY2018
The study achieved all the BTX 1503 program goals, indicating that it has an excellent safety profile, is very effective at reducing the number of inflammatory and non-inflammatory acne lesions, and provided an improvement in patient rated satisfaction
BTX 1503’s (on average) ~47% reduction in inflammatory lesions was greater than any other FDA-approved topical acne product for which data is available after four weeks of treatment

Phase 2:
However, the phase 2 results showed the primary endpoint in reduction in inflammatory lesions did not achieve statistical significance (even when considering AUS v US).
But, the secondary endpoint of reduction in non-inflammatory end points was statistically significant
It is the inflammatory lesions that are important.
Non-inflammatory lesions are simply comedones or pimples that have not yet broken through the skin are are not yet inflamed.

Ultimately, my outsider objective view is that:
The phase 2 trial was not a success
The market evidently agrees with me given the share price collapse
Progression to phase 3 is not guaranteed.

I'm impressed with the caliber of management of this company, but I am not yet convinced by the BTX1503 product.

To the bulls, why are you confident that the trial will continue into phase 3? Why are you confident that the market is wrong and that you are right and that we will return to the highs of old? Has the market overlooked the results of the phase 2 trial?

Willing to be convinced to buy in for a speculative trade -- I can't consider this an "investment" on current data yet.

T.E.P.

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I’m pretty sure that it’s incorrect to say that the Australian results did not achieve statistical significance.

Also, why would non-inflammatory lesions not be important if they were lesions that had not YET become inflamed or broken through the skin? Would it not be better for the treatment longer term to be able to nip these in the bud?
BOT Price at posting: 4.2¢ Sentiment: Buy Disclosure: Held
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Objective Views on Lead product: BTX 1503 (Acne), page-8

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Objective Views on Lead product: BTX 1503 (Acne), page-8

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