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Wednesday, April 27, 2022 6:21:23 PM
Summary of Key Points From The B.Riley Conference
(OL) Open Label
(CMS) Cognition Maintenance Study
(CSF) Cerebral Spinal Fluid
(CP) Citizens Petition
(CUNY) City University New York
Mention of Short CP and Western Blots being pushed by shorts.
Short CP succeeded in bringing the SP down. Forced many investors to run away and perhaps reconsider another time when there is better investor confidence.
Despite short CP instilling fear, data has not changed.
FDA responded to the short CP. No evidence of fraud or manipulation. FDA is about being data driven - safety and efficacy, hence the allowance of SPA for PH3 trials. Short CP not an appropriate topic for the FDA to address and was utterly denied.
Investigation is not about clearing Cassava Sciences. It is about CUNY doing a thorough investigation to ensure the integrity of scientific data and evidence in every step of their work and their data.
PH3 program is complex, lengthy, and extensive. Delays were expected.
Remi gets investors feel an information void but it's how the PH3 3 trials are designed. Clinical data must be blinded to ensure privacy and integrity of data without external interference from any entities.
Not much they can say or disclose regarding PH3 progress other than key metrics e.g. PH 3 clinical site enrolments, etc.
Number of PH3 by other sponsors and companies may have failed due to inclusion/exclusion criterias that were rushed to get patients in for trials. Also significant pressure from Wall Street. Cassava Sciences wants to be careful not to repeat those mistakes, hence why PH3 clinical site enrolments are slow at the moment. There is a long list of inclusion/exclusion factor that ust be considered when recruiting patients.
Purpose of PH3 screning via CSF of P-tau 181 or PET scans, is to confirm and ensure patients actually suffer from mild-moderate AD.
Full data set of OL study by end of the year.
100 patients treated with OL Simufilam. Good start, good data point for study.
Participants have option t enrol on CMS. CMS becomes placebo controlled double blinded study.
CMS responds to all subjects that are treated on OL for a year, what happens when half of those patients are taken off on OL Simufilam. Stay tuned! We don’t know yet!
50-100mg Simufilam. Would have to see dramatic effects to see statistical difference. Looking mainly at directional trends – ideally placebo to separate from the drug arm, and if we see separate and pattern maintains, it confirms their basis for their drug and the Filamin theory which is a historical medical breakthrough in the making!
Hypothetically, complete enrolment by this mid-Summer. By next year, the company should hopefully be allowed to unblind the data from CMS.
Important for Remi and the company to understand biological effects of the drug. Filamin is relatively new compared to Amyloid theory which has been around for years with little to no results.
Filamin is still a new theory. Important to observe biological effects. Important to look at CSF. 25 patients from OL study were selected from 6 months. Saw nice drops from key biomarkers – P-tau 181, etc.
Plans to look at another 25 subjects for 1 year on OL Simufilam
Why only 25? Remember, this is CSF. Procedure important for ethical and practical reasons.
Few patients may overlap. Consider that they may have to volunteer for CSF hence data irregularities at times.
Last response regarding their current finances: $233 million cash. They have enough to get them to the end of PH3 studies.
Overall sentiment from the conference? Remi was much, much more confident. Threw out all the facts, data, and science investors needed to hear in order to boost overall confidence.
“Data is permanent, but share price is transient. In Cassava Sciences, we are driven by science and data.” - Remi
Recent SAVA News
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