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Acne Phase 2 - Probability of Success and Likely Market Response, page-57

  1. 286 Posts.
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    @aburbe - 100% agree with you that this is like comparing apples and oranges. That's the point I was trying to make i.e. that whatever the acne trials show - there will be a tendency to compare across different trials - which has no scientific basis - but will be what many may do. And there is ready access to trial data that could be used (incorrectly) to cast doubt over BTX1503’s potential.

    I also recognise that the trial lengths were of different duration - and note that the BTX1503 Phase 2 trial is of a longer duration than the Phase 1 trial - which is a much smarter approach to adopt and IMO is likely to place BTX1503 in a solid position to show what it can do!

    But perhaps the more important point I was trying to make is that the market can be somewhat challenged in how it interprets results - and without a clear difference between the active and placebo arms - there can be a tendency to misinterpret. Also - if we have results that are pretty close to Epiduo - no doubt down rampers will make way more of it than they should (as it will overlook the benefits BTX1503 is likely to offer over competitors in terms of efficacy / tolerability / compliance etc.)

    And without wanting to pick an argument – I note that you reference BTX1503 as outperforming EPIDUO (and ACAZONE) – but this is only the Phase 1 results and based on 18 subjects. So – saying that 47% reduction demonstrates that it is ‘better’ than competitors (at 42% and 38% respectively) is a pretty bold claim to make. Yes – the 'number’ is bigger – but the indirect comparison does not provide any valid basis for a superiority claim - even if it may be suggested to be so.

    This does tend to set the expectation that "all will be fine" - but my concern is that if the Phase 2 results don’t re-confirm this anticipated superiority we may see a confused or muted response from some quarters.

    I'm certainly not trying to talk down the prospects of success in the acne trial – just trying to play devil’s advocate to my own (potentially overly optimistic) of where this will all end – as I found myself assuming the results would be positive – and had to remind myself that getting through Phase 2 remains the toughest challenge for any new product.

    We get through Phase 2 successfully and we're all laughing (well - laughing more than we already are!).

    But the way the SP has held up over the last few weeks of global turmoil and carnage (coupled with the response to the CR) has been very reassuring….….although I'd still like to see the full set of Phase 1 psoriasis results...a bit puzzling that we have yet to see those



 
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