SUMMARY: Endpoints and STAT news are reporting that Biogen is coming under intense scrutiny when it comes to their failed drug aducanumab. According to the Endpoints report “On Monday Baird’s Brian Skorney — a prominent Wall Street analyst — kicked off the week with a scathing assessment of the data Biogen has presented to date and a declaration that barring a deus ex machina — an unlikely savior — there’s no way the FDA would approve a drug on this data, outlining a variety of issues that would freeze any other drug in its track”.
I have to admit that when Jim Kramer went on a rant about Biogen’s stock based on their press release I was highly skeptical. This, after all, is a company in trouble. They really don’t have any drugs in their pipeline, key executives have been leaving in droves and I have personally seen a lot of talent leave the struggling biotech.
My position, all along, has been simple; let an independent third party review the data to determine if the drug is a potential treatment for Alzheimer’s.
To make matters worse it seems the FDA may come under political pressure to approve the drug because it offers some hope which is better than no hope. One can only hope that the FDA does the right thing and declines to approve the drug if the data is not meaningful.
I worked closely with some very smart R&D people in my career and I have never witnessed any of them “reanalyze data” to look for some way to save a failed product. In fact when we were reviewing some data for a new drug candidate the R&D team requested a budget to hire an outside team review the data to ensure we didn’t miss anything.
If the FDA declines to approve this drug and investigation should be launched into potential stock manipulation. Trust in the pharma industry is very low hopefully the FDA will do the right thing and ask for ALL the data.