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Replies to post #369060 on Anavex Life Sciences Corp (AVXL)
08/04/22 6:48 AM
08/04/22 7:22 AM
08/04/22 12:29 PM
1. Clearly whatever paper he is quoting is nonsense as we have a plethora of company data showing expression of S1R directly correlating to therapeutic effect. Can't speak for M1, but Blarcamesine is much more than just M1. We know this, it can be viewed in the PDF on sotcanalytics.com. In any case, 3-71 was developed to focus on potency of S1R/M1 specifically.
2. Anavex does not require an IND. And yes they had planned years ago to get one, but then they decided to run trials in Australia. Running trials in Australia was a great idea because Anavex was a no-name biotech and Australia was willing to pay for a large percentage of the trial. Additionally, the TGA and FDA regularly approve the same drugs based on trials ran in each others countries. To a lesser extent the same is true for the EMA and the FDA.
3. Nearly complete nonsense. Continuity of Attention blew it out of the water. A cursory glance at any company document would show this. MDF-UPDRS Part III was met with statistical significance of 0.024. Sleep is the only subjective (lightly merit-able) complaint here. Quote from slide below:
"For a characteristic and debilitating sleep problem in Parkinson’s disease there was a marked and marginally significant improvement (p = 0.054) in those affected by REM sleep behavior disorder, which was detected as early as 8 weeks after beginning treatment: 50% subjects on 50 mg dose improved from REM sleep disorder ‘affected’ to ‘not affected’, compared to 15% in placebo arm (p = 0.054)"
4. Clinicaltrials site updates slowly and its not up to the company. Even IF they did change the endpoints, what is the point of this complaint? All of the endpoints are gold standard and the trial data is blinded. So... Anyways
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