RespireRx Pharmaceuticals Inc (RSPI)

[neuroinv]

Although those are obviously also all possible motivators, I don't agree that the competitive issue is moot. For example--in the case of the FDA's specific (if they even get specific) comments about CX717, competitors will have two sources for obtaining those details: the FDA, or Cortex. While I think the FDA, or at least certain divisions, has been cowardly and dishonest, I do not believe they are corrupt. Before someone raises the Provenge situation here, it should be noted that the conflict-of-interest issues raised have to do with Advisory Committee members, outside consultants brought in to do precisely that, not FDA staff members per se. So I do not see the FDA as a likely leaker, though obviously it is possible.

As to Cortex: Even if, over drinks by the pool in Boca Raton at next year's ACNP meeting, a Cortex scientist lets slip some detail to another scientist, and it gets back to Lilly....there will be some time-delay involved, and this is information which pertains to rapidity of development. If a competitor finds out about a shortcut a year later, it's less of an advantage to them than if they find out now.

The other motivating factor for nondisclosure I didn't previously mention: Not embarrassing the FDA. If Cortex plans to have a clinical trial program in the US, they are best-served by not publicly humiliating the regulatory agency which has its boot on the throat of every small bio company. The firebrands will disagree, I was one once, but at present, a frontal assault on the FDA would be the bioequivalent of the Charge of the Light Brigade ("Into the valley of death rode the 300"). It did not turn out well for them.

Gary Lyons of Neurocrine is no wimp--he's an ex-Marine, and is anything but passive. If you look at what he said (or listen to the replay) about the FDA's egregious dishonesty, all he did was lay out the material facts, without any of the rage that must have been right under the surface. Lyons has a GSK partnership and $165 million in cash, and he isn't (at least yet) taking an aggressive tack to the FDA. If he isn't, we don't want Roger Stoll, with $20 million and no partner, leading the way instead.

Looks like I digressed a bit, but it's relevant enough.

NeuroInvestment