Agree 100% here. There's still a decent market for IIH. IMO, they will proceed with the trial either way.
Given that recruitment has been slow, they had two options - (1) to just proceed with the trial as it is and waste SHs time and money (likely raising of more capital) or (2) pivot and seek approval to change the secondary endpoint to allow peeps outside of the current PMD limits to enrol, which means a lower sample size and a cash and timeline neutral situation. So, as the trial ticks along with the current eligibility criteria, we can continue to recruit and wait for the market analysis.
Re: the market analysis - we need to better understand what the issue is with having the other GLPs available, when Presendin is designed to be significantly more effective in lowering ICP (it's quicker and longer lasting). Do they believe that more women being prescribed these GLPs will mean lower rates of obesity going forward, which will lower the incidence of IIH in the future? They used the term "acceptability" of Presendin. They needed to be clearer on this point.
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- Ann: Phase III Clinical Trial Update and New IIH Market Analysis
Ann: Phase III Clinical Trial Update and New IIH Market Analysis, page-114
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