Cassava Sciences, Inc. (SAVA) has seen a push of 7.26% in the aftermarket because the company announced that petition filed by citizens on behalf of short-selling clients is denied by the FDA. However, the last trading session closed at $53.05 with an increase of 7.78%.
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FDA Denies Citizen Petitions – What’s happening?
SAVA announced on 10th February 2022 that a Citizen Petition submitted by a lawyer on behalf of short-selling clients was dismissed by the US Food and Drug Administration. Moreover, four supplements to the Citizen Petition filed in August 2021 were also rejected by the FDA.
The company thinks that while the news is pleasant, it is not unexpected. SAVA has always maintained that the charges are false, and it thinks that the stock market players should not take the FDA’s citizen petition privilege lightly.
Launch of a Clinical Website – More About it
On 23rd December 2021, SAVA announced that the company has launched the clinical website. People with Alzheimer’s disease can use Rethink-ALZ.com to evaluate if research involvement is appropriate for them by filling out a patient- and caregiver-friendly pre-qualification questionnaire. If a person expresses interest, he or she is offered the choice of choosing a clinical trial location that is closest to them. The person can then opt to contact the site or request to be approached for pre-screening.
The company believes that clinical sites all over the country are very enthused about the potential of oral simufilam to affect Alzheimer’s disease. In addition, Rethink-ALZ.com is committed to improving patient satisfaction and enrolment in both of the ongoing Phase 3 studies of oral simufilam in Alzheimer’s disease.
Second Phase 3 Study of Simufilam Initiated – Latest News
SAVA announced the initiation of the Second Phase 3 Study of Simufilam on 18th November 2021. Moreover, the purpose of this second Phase 3 research is to assess the safety and efficacy of simufilam in around 1,000 Alzheimer’s disease patients among clinical sites in the United States and Canada for a total of 78 weeks.
Furthermore, the U.S. Food and Drug Administration has granted Cassava Sciences Special Protocol Assessments (SPA) to perform its Alzheimer’s Phase 3 research (FDA). Lastly, FDA examined and approved the essential design aspects of each Phase 3 study protocol in the SPAs document.