MY TOPLINE QUESTIONS FOR CHRISTOPHER J. MOREAU, CEO @ AP My best guess as to the IPF/CC clinical trial is it will be a stepping stone to another Phase 2 study in the same vein as Bellus Health taking a second bite at the apple. I'm finding it hard to believe a clinical trial of just 20 people is powered enough to reach statistical significance. More-so, there's no placebo, it's open label, and has only 1 arm with one dose (20 mg). In every category it would appear the design of the trial is lacking/slacking on getting to a definitive outcome short of some OVERWHELMING DATA. It's similar to how the COVID angle played out. It was hyped up until the very end when the CEO came clean/confessed there simply weren't enough people in the trial to reach statistical significance. I fear the same "cost efficient" strategy is being played out with IPF/CC and it's merely another chapter in a long story the CEO plans to milk to the milky way/infinity and beyond. If you look at where Bellus Health has been with their CC study to where they're at now, you will see how they drastically switched the script as it relates to the number of people in their clinical trial and pathways to getting to statistical significance. They built in multiple avenues with multiple doses and multiple percentages of effectiveness (30% 50% 70%). It's as if they put a chip on every bingo number/covered all the bases/angles for success. Algernon has but one simple angle which needs to be more than 50% effective at reducing cough in the CC portion of the study. It's one shot at statistical significance with one dosage. What if Ifenprodil reduces cough by 40% versus 50%? Would that not seem significant? It likely would be but for pigeonholing yourself with what likely is an arbitrary number. Yet, the market would view it as a failure because bonehead AP simply can't get any narrative straight. Bellus Health is conducting a 6 Arm study with 300 patients and multiple (3) doses. Algernon is conducting a 1 Arm study with 20 patients and one dose. IMO, it simply doesn't add up to snuff. Having said that, the CEO needs to be held to account for putting out these tiny clinical trials and acting as if they're adequate enough to reach statistical significance without some otherworldly luck needing to be involved to get to meaningful results. The overall repurposed drugs strategy is being exposed as simply a hustle from one underpowered clinical trial to the next. IF the EOP2 Meeting results went well then the next step would not have been to pack up and go home would it? It would seem to have been attempting to find a partner to push the COVID angle forward. Instead it was a surrender which tells me the FDA told AP it's tiny trial was not worth the effort to go to a Phase 3 WITHOUT ANY STATISTICALLY SIGNIFICANT DATA. The COVID game was over when the Topline Data was reported. Moreau just kept the game/drama going because there's literally nothing else significant to talk about until the IPF/CC data report.
Topline Questions for Christopher Moreau.
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Do you truly believe a Single Arm 20 Patient study for IPF & Chronic Cough as designed by Algernon is powered enough to reach statistical significance, or is the IPF & Chronic Cough study most likely underpowered to reach a statistical significance?
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You have consistently referred to Bellus Health as “a pure comparative” to Algernon for Chronic Cough. Why are the study designs between Bellus and Algernon so drastically different, and do you believe Bellus Health has given themselves more chances at success given the design of their study?
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When will you hold the next webcast that will allow shareholders to see/ask questions in real time?
BB