$sava or Cassava Science is testing simufilam in 2 phase 3 trials at about 200 trial sites (primarily in the US but a few dozen outside the US) for the treatment of #Alzheimers. Both trials have nearly fully enrolled with over 1900 patients. One trial should complete and read out in Q4 2024 or Q1 2025. The drug is a pill you take twice a day.
Their were two phase 2 trials. Phase 2a was a 64 patients trial for 1 month. The patients showed remarkable improvement in a wide panel of bio markers. Phase 2b was a 200 patient open label trial and patient cognition performed much better than the typical placebo populations in other studies.
Mild patients with an MMSE 21-26 actually improved cognition by a total of 3 points over 18 months as they continued into an additional 6 month study. Most significant results of any AD trial.
Additional data is being reported by $sava on Oct 27 at CTAD for the extension study. A very experienced biotech statistician, Suzanne Hendrix, is presenting new data from the extension study. This could be a positive catalyst. I hope to hear her give reason why she thinks the drug is disease modifying to Alzheimerโs.
At CTAD they are presenting MRI safety data from the phase 3 trial and a paper that independently verified the Mechanism of Action of the drug.
Zero adverse drug related safety events occurred in phase 2. The phase 3 trial just passed a key Data Safety Management Board as they approved for the trial to move forward as planned.
Typically drugs in large phase 3 trials are valued at $20B or $500 a share, but $sava now trades at 623m or $14.86 a share as of close on Friday. Drugs that receive a nod from the FDA for AD will be valued at about $40B or $1000 a share. The reason it trades at such an enormous discount is the company has been a victim of a very ruthless and well coordinated short campaign that is short about 40% of the stock.
There are pending investigations against the company that were all spurred by short sellers and competition. CUNY (university the preclinical research was performed by Dr Wang), SEC (from a whistleblower complaint by short sellers, and DOJ (from complaints by the same short sellers), and ORI/NIH (from allegations by short sellers. I am not buying any of the allegations by the short sellers and I think they are dragging good people and a good company through mud for profit.
A CUNY investigative report was illegally leaked to https://t.co/jMJCf5mVqZ (then subsequently written about by the WSJ and the New York Times) by the investigative team at CUNY that claims research misconduct but does not name one policy violation. He provided about 1600 images of his work and they claimed he did not give them information about his experiments. They had a forensic image expert work for three months than quit.
The report said they could not confirm Dr. Wang committed any of the 31 allegations by short seller.
It may not rule in the researchers favor, but very unlikely to say any research was manipulated as the short seller accused. They claim to be acting on the investigative report this month.
SEC and DOJ will likely resolve before phase 3 is complete. NIH/ORI may rule against Dr Wang, but very unlikely to interrupt funding or rule against Cassava in any way.
$sava collaborator Dr. Wangโs work has been corroborated by 4 different institutional labs. One experiment was rerun and republished by an independent group of scientists. But preclinical work is not important any more given they already patented the compounds.
The stock could continue to feel pressure until phase 3 or some clearances could come in and bring it up to $50 before then. Either way it is radically undervalued and I think represents the biggest investment opportunity in the market.
This can serve to catch up those that are new to the story and I hope it shows you the positive potential of the company despite the negative press they have received.
The U.S. FDA has granted Emergency Use Authorization for Novavaxโs COVID-19 vaccine, Adjuvanted (2023-2024 Formula) to prevent COVID-19 in individuals aged 12 and older.
BREAKING: US $80m Jet Missing | Flying With No Pilot
Military officials are searching for a jet after the pilot ejected. The jet has not crashed and has continued to fly on autopilot.
"The public is asked to cooperate with military authorities as the recovery effort continues"
When 2 groups of penguins meet on the road, they stop for a short exchange of information. When one of them moves in with the wrong group, a friend goes after him to bring him back๐๐ง๐ง๐ง