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Re: Alzy B post# 18517

Tuesday, 11/02/2021 3:08:46 PM

Tuesday, November 02, 2021 3:08:46 PM

Post# of 21540
It's all a guess since the two aren't yet competing for the same patients, with SNPX going for the more severe on the AD range.

Sava is running 2 larger trials (less severe is likely to require more patients, most often due to misdiagnosis and slower decline). One will be complete in October 2023. The other almost a year afterwards. My guess is that if the first trial completes and hits on already approved FDA endpoints, then they would be provisionally approved and marketing the drug in 2024 while the second trial continues to gather data on both efficacy and safety. That's a guess and FDA may want both complete.

Not so clear a path with SNPX. Our P2b controlled data will read out in around a year. CEO has stated that although its not impossible, it would be unlikely the current trial would gain approval even with other previous studies. He wanted to be conservative in that measure. Now we have the new "wildcard" dosing trial to commence next year that we have no details on yet as well as additional CNS trials. At some point if we continue to improve cognition in these trials, we would likely get approval but we don't really know when. If we are required to run an additional, larger trial after results next year it likely would kick off first half of 2022 and run most of 2023, potentially reading out around the same time as SAVA's first of 2 current trials. Once again this is assuming a smaller trial (maybe 400-500 patients) and a shorter duration (6 months) for us than SAVA is currently being asked to run due to a more severe AD population.

All said, its hard to argue SAVA isn't ahead of us, but there certainly is an argument. Much better argument is that bryostatin is the superior drug IMO. Entire post is JMHO
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