[ad_1]
The cassava saga continues as chef Rémi Barbier comes out with guns against accusations that biotechnology has deliberately misdirected investors on a recent reading of Alzheimer’s disease.
Last month, a citizen petition filed with the FDA questioned the scientific integrity of the company’s clinical trials for the Alzheimer’s drug simufilam and asked the agency to put them on hold.
The whistleblower’s petition detailed serious concerns about the quality and integrity of laboratory studies surrounding this drug candidate and supporting claims relating to its effectiveness.
Although the petition data comes from publicly available information, the whistleblower is not named and the document is signed by attorney Jordan Thomas of Labaton Sucharow on behalf of his clients.
RELATED: Lab Appointed By Cassava To Save Alzheimer’s Data Says It Wasn’t Involved, Returning Biotech Stocks to Plummet Again
Cassava spoke out against the petition with a “true and false” coin, trying to defend itself against the allegations. Quanterix, a digital health company focused on digitizing biomarker analysis, was one of the core elements of cassava cited in the rebuttal (PDF).
Last week, however, the lab company denied any involvement in the preparation of some of the data in question, putting greater pressure on cassava.
In the past few weeks since the petition was published, approximately $ 2 billion in value has been wiped out of the business, Barbier said. Hence another rebuttal.
Let’s be clear: I think these claims are false. The allegations claim that our science is unlikely, unexpected and unique to cassava science, and therefore everything is an elaborate fraud, ”Barbier said in an audio and written statement (PDF). “According to these criteria, all drug innovations are fraudulent. We intend to vigorously defend ourselves and our stakeholders against false and misleading claims.
He also alleged, as many attacked biotech CEOs often do, that a company or organization with a short stance in biotech is to blame. Labaton Sucharow revealed in a follow-up response to the petition that customers that the company represents positions in cassava.
When I first read the allegations I felt stunned and confused [] But I think what we’re seeing right now is not an ordinary short seller betting that our data is going to disappoint, ”said Barbier. “For me, the short attack on Cassava Sciences is unprecedented in its audacity, scope, immediacy and intensity. He feels very organized and well funded. We get the impression that whoever is behind this effort wants to make a lot of money quickly, to the detriment of our science.
RELATED: Cassava Defends Alzheimer’s Science After Citizen’s Petition Raises ‘Serious Concerns’ Over Clinical Studies
Cassava is developing simufilam as a different approach to treat Alzheimer’s disease. The therapy does not try to remove amyloid from the brain, which is what many competing drugs aim for, but rather tries to stabilize a scaffold protein called filamin A.
The biotech recently reached an agreement with the FDA to conduct a phase 3 trial. The petition claims that the link between filamin A and Alzheimer’s disease has not been established.
Barbier’s dramatic language seems to have had the desired effect; shares rose 9% to about $ 59 before market on Friday.
|
Sources 2/ https://www.fiercebiotech.com/biotech/cassava-ceo-dazed-and-confused-takes-to-biotech-defense-handbook-blames-short-sellers-for The mention sources can contact us to remove/changing this article |
[ad_2]