Today, investors in Cassava science (NASDAQ :SAVA) see a lot of red. In fact, SAVA stock has lost over 25% of its market cap today on a pretty heavy catalyst.
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Yesterday, a statement of concern was filed with the Food and Drug Administration (FDA). This document called on the FDA to end clinical trials on cassava for its main treatment for Alzheimer’s disease. The statement of concern listed a number of issues with the science behind the company’s proposal to initiate Phase 3 trials of this treatment shortly.
The validity of clinical biomarker data, the methods used to conduct research, and the final conclusions the company relied on to move forward with the clinical trial process are all challenged as a result of this petition. Thus, investors today assess a much higher risk in this biotechnological action.
Let’s dive into Cassavia’s response to the allegations.
SAVA share down following weaker investor confidence
Indeed, it appears that Cassava takes these allegations very seriously. Today, the company responded to the series of allegations, with a lengthy rebuttal to each specific concern.
The company noted, “As a scientific company, we stand for facts that can be evaluated and verified… It helps people make informed choices. It is important that stakeholders separate fact from fiction, which is why we want to tackle the allegations head-on. As a result, the company has gone line by line to address various concerns.
Among the rebuttals listed were the following:
Biomarker data was generated by Quanterix Corp., an independent company, and presented at the recent international conference of the Alzheimer’s Association. Western blot analysis is fundamental to the biotechnology industry. Western blotting is a standard laboratory technique used around the world to detect a protein of interest. The “halo” effects in some bands are a direct result of very dense dark charge control bands. A panel of independent peer reviewers believes these changes represent an improvement, as well as significant improvements in two other behavior tests.
As of the publication date, Chris MacDonald does not have (directly or indirectly) any position in any of the stocks mentioned in this article. The opinions expressed in this article are those of the author, subject to the publication guidelines of InvestorPlace.com.
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