Miscellaneous thoughts:
1) Tran's work at XenoPort and Lilly would not seem 'academic' in my view. He was running clinical trials at XenoPort and for duloxetine/Cymbalta at Lilly. That means design skills and dealing with the FDA.
2) RD and analgesia. The fact that opioid receptors can influence respiratory function 'downstream' does not mean it has to be a two-way street. The receptors CX717 hits for RD are not opioid receptors, and the animal studies showed no effect on analgesia. We can't be sure that is the same in humans yet, but downstream interventions do not necessarily affect upstream processes.
3) There is no new toxicity issue. If that was, it would have been material.
4) Dr. Sanfilippo. I've never heard of him, not that this in itself means anything. But the Yale Asst Professorship doesn't imbue him with any credibility. In the early 1980's I was at Mass General and then for five years had an extremely low-level appointment to the Harvard Medical School faculty. That doesn't give me any credibility either. And I knew plenty of Asst Professors--the big Ivy League medical schools give out titles instead of paying the going rate--some were good, some were not. It doesn't prove anything one way or another.
The content of his piece is also very superficial. He does not differentiate between the two divisions of the FDA; CX717 appeared to have a therapeutic index of--I don't recall the exact number, but it was far better than a lot of drugs on the market; Fragile X was done with CX516, DARPA trial was s---. I know he didn't do his homework, or he has an agenda, or both.
5) I would think 701 would be submitted to Neurology, probably aiming for AD initially. I cannot imagine them going to Psychiatry.
6) Dew's essay:
A few things are overlooked there. First, everyone has dropped MCI, because as it turns out, Neurology paid lip service to MCI as an indication, but has made it clear in private that no drug is going to be approved for memory impairment in MCI.They have to go through Alzheimer's first (OR, as I have been suggesting, schizophreniform cognition). That ruled it out for Cortex too. EDS was 'dropped' because ADHD looked better. In hindsight, one can argue EDS would be better, but I certainly didnt see it that way at the time. The conclusion that no indication has shown a Cortex drug safe and effective--I would argue that ADHD has thus far looked that way, but Psychiatry won't let them prove it. Finally, the other reason they are casting about for a low-impact indication is that the two most obvious ones, schizophrenia and depression, were sold off for a low price 8 years ago. So they lost sz and dep to Organon; ADHD to FDA cowardice; EDS to DARPA's failure and an anticipation Neurology will be tightening the screws on such applications. Thus it's not so much a drug searching for an indication, so much as the most obvious indications have been taken out of play by different factors. So they are picking from an abbreviated menu. For now--Schering Plough could change that.
NeuroInvestment
