Note: This is an opinion of one author
When first looking through the citizen petition – the evening of Aug 24th, my initial reaction was amusement. Was this yet another unfounded document? Most petitions are, after all, dismissed. But reading through the details on this one slowly gave way to shock. After all, a few of my investor friends and I were just celebrating SPA approval for the phase 3 studies of Simufilam.
The petition looked scary. There was the mention of a whistleblower. Was there somebody within Cassava or working closely with them who wrote this? The petition had a lot of scientific details which I did not fully understand. Were these western blot issues real? The AAIC poster also started to look a bit sloppier as some of us began to notice the graphs being different as highlighted by the petitioner.
Notwithstanding its motives, the petition was scary and forced me to sell a portion of my long position. This was no longer a question of drug efficacy, it was one a lot more serious – was there fraud?
Cassava’s initial response was not convincing in that they did not address all the allegations, and serious questions remained on the company’s processes around biomarker analysis. Their bedrock randomized placebo controlled phase 2b study results were now questionable. The statement from partner Quanterix, while meant to be clarifying, made things worse. Cassava had to later further clarify the Quanterix response. It was getting messier every day.
A drug with such promising results, a strong board of scientific advisors, and so much hope for Alzheimer’s patients could possibly fall apart because at its core were faulty experiments with allegedly manipulated results. Was there consistency in the mouse models for the drug? Were their experiments repeatable? Were AD patients feeling better because of a sugar pill?
However after much discussion and diligence with fellow investors, I did come to consensus on a few things which gave me a bit of pause and I will include this in the next few articles where I reiterate a cautiously bullish outlook for Cassava. (Please remember to read the sites disclaimer on any stock advice). There will also be articles from data analysis experts who will take an in depth look into the p-tau data collected via blood plasma assay by Quanterix.