It seems to me there are two distinct camps and an in between thinking approach to the adu debacle and perhaps biotech investing in general.
1) A sense of fairness and what is perceived correct driven by a combination of close experience, emotions and general outlook on life and from that deriving what seems right and should be defended
2) A cold data driven scientific rational view on what is the best answer
And then there is the in between mix of 2 & 3 plus a whole bunch of nuances.
My take on the $biib nuances:
The FDA going against the advisory committee’s very clear message re. adu seems on the face of it arrogant and plain wrong.
However, taking into account that there are in fact some patients who have publicly stated there hope for approval as their experience have been that adu improved their life quality and has provided hope against hope. How much is that worth and should the FDA ignore those pleas and go with the cold data driven advice?
The FDA might have done the only thing they could, which was to require a P4 and be in a position to withdraw marketing approval anytime.
Yes it is a messy situation and one where folks will be understandably upset either way.
The accelerated approval, P4 and ability to withdraw marketing approval is also an opportunity to put a stake in the ground on the amyloid hypothesis.
Adu has so far been shown as one of the best plaque removal drugs. If that ultimately is shown to do nothing to reverse, halt or meaningfully slow down dementia or if it actually does, science understanding will have moved forward either way.
It is not down to the FDA to define drug research direction to private companies, but to evaluate their trial proposals for safety and ethics. I feel certain there would be uproar should a government agency start dictating the direction of scientific research and private/public company spending.
The professionalism of advisory board members has seemingly been ignored and some of them have decided to withdraw their services in a mix of rational disagreement, hurt pride and outright disgust.
The FDA must be very careful in handling such situations as there isn’t an endless supply of the best and most diligent advisory board candidates for every field of medicine. We need those boards for the process to have credibility.
It may also be that advisory board members later feel they acted in the heat of the moment, but we will never know.
The adu decision is not a war against Anavex. It will not affect the ability of A2-73 being approved on appropriate data. It might actually make it easier as A2-73 just have to beat the best and the most recent best isn’t very good.
