BOT 1.56% 31.5¢ botanix pharmaceuticals ltd

Antimicrobial platform - BTX 1801 Phase 2a clinical study, page-82

  1. 45 Posts.
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    You may be right but since they would have submitted the study brief as part of the End of Phase 2 meeting request already simply share the finer points so we can evaluate the lucidity of the plan. They want us to approve millions of options, least they can do is provide disclosure.

    When you say a lot larger is that 2,3,4,5 the number of patients in the single Phase 2 ( think it was 300+ before) Since FDA requires 2 well controlled efficacy studies what is the total number of patients needed to enroll?
    FDA also requires long term exposure data for 1 year, how many patients are needed? Are there any other studies required before approval? The bar for success in Phase 3 is higher than Phase 2 so simply repeating same outcome isn’t sufficient. Will need statistical difference across both studies and all endpoints to ensure a high likelihood of approval.

    If they are able to make the same 30mil AUD ( as of last December) cover all that plus the past 6 months burn ( was almost 7mil quarter before), 2 years running capital for the studies, BTX1801 and BTX 1702 then that would be miraculous. Hoping you are right and no dilution.

    For everyone ( including me)sitting on a loss knowing these details may lessen the tax loss selling at the end of the month.
 
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