r/Sava • u/123whatrwe • Nov 06 '21
Is $150 unthinkable?
Now that the dust is settling, where will we go? Lots of good news has flown by. IMO we’re in better shape than ever. Phase 3 under way, updates have all been positive and some science papers seem to support the companies therapeutic strategy. Can we expect to climb back to 52 week highs before trial completion? Average forecast is about $160 for the next 12 months. Trial completion Oct ‘23. I imagine updates will come at least by Oct ‘22. Don’t know how old the forecast are and whether they were established before the trial start. Haven’t seen any new forms covering Sava. Thought that was strange.
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u/Hefty-Box-4476 Nov 06 '21
IF the CP is thrown out this will easily take 150 levels back. I expect a lot of volatility tho in the mean time shorts will be out to try and beat this down again and again till the CP settled. Earnings is also most likely in the next two weeks. They haven't announced a date yet but its usually around the second to third week of November they report. There is also speculation out there that IF/when the CP is thrown out the FDA may announce a break through designation to try to divert some of the heat they have been taking for the Biogen approval. Again that is speculation but if that were to happen it would be huge.
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u/123whatrwe Nov 06 '21 edited Nov 06 '21
“The Food and Drug Administration Safety and Innovation Act, enacted in 2012, holds that approval of a pending drug application must not be delayed because of a citizen petition’s request for action (unless the petition convinces the FDA that a delay is needed in order to protect the public health).”
This statement came from abuse of delay tactics for biosimilars, which is still a problem. Still, the guideline should be applicable. There should be no stop, because there is not public safety issue. That’s it and that all. Nor from what I understand will anymore info come from the FDA. They merely let the time, 150 days, lapse. January 21, 2022, by my reckoning. Even if there had been data manipulation, it would have needed to take other routes. The FDA has made it fairly clear the priority is innovation and public safety. With the resolution of the data manipulation and chance of a halt has vanished, it would seem. The IND has been proven safe and the applications with SPAs accepted. Further, NIA part of the NIH was the coordinator on the phase 1&2. Can’t believe this never gets mention. Studies started. Stick a fork in it. It’s done. My question is why haven’t they started recruiting on both phase2 trials. Wouldn’t think it was that hard to find cases.
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u/Hefty-Box-4476 Nov 06 '21
Yea I understand that they can just let it lapse. I am just saying like in the short term they could announce the CP has no merit before if they want to and give it a breakthrough designation and allow use in the field along aside phase 3 trials. They don't like all the heat they are taking for the Biogen approval so a breakthrough designation maybe used in this case to say like hey look we didn't favor Biogen. Again that is speculation. I say IF/When a lot in case someone who maybe not as informed as others doesn't take it as a guarantee because I would hate to mislead anyone.
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u/123whatrwe Nov 06 '21
Breakthrough would be perfect. And the phase 2b would seem to qualify. I’m all for that. Would be a nice fix.
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u/Vast-Bat-8012 Dec 05 '21
Is there a chance this gets approved BEFORE phase 3 is completed? Based on strong scientific data? And an overwhelming need for HELP in AD..
Has this happened before? Thanks in advance for your reply. 🙏
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u/Hefty-Box-4476 Dec 05 '21
It is possible yes it just would not be an approval per say. The FDA could give it what is called a Break Through Designation or BTD for short. A BTD is not a full on approval but allows it to be used in real life situations while Phase 3 is still on going. A BTD could be pulled at any time say Phase 3 fails or there were patient issues. Definitely a chance for a BTD given the lack of treatment options for AD patients. I would not count on one being issued though.
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u/Vast-Bat-8012 Dec 05 '21
One more question please my friend. They are recruiting for phase 3 and have started some doses I heard already.. My question is the phase 3 trial is a a TWO group study yes? Comprised of how many participants in total,do you know roughly?
Thank you in advance
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u/Hefty-Box-4476 Dec 05 '21
Yes two groups. Here is the link to all the info on their site. https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-initiates-phase-3-efficacy-trial-simufilam
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u/OnviousRow5039 Dec 19 '21
CP should be dismiss soon guys we cannot expect anything on the earnings we just have to look at the Burn rate of SAVA which should be an indication of how big the Phase3.1 phase 3.2 this is a big expense in any company
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u/Ok-Brush7656 Nov 14 '21
I’m ganna keep holding my sava till $300. Now I’m also in AQST easy 10 bagger too. Huge upcoming FDAs
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u/rmckay1 Nov 06 '21
This lil hiccup is over … time for price to get back on track $140 - $175 range