Replies to post #1407 on RespireRx Pharmaceuticals Inc (fka RSPI)

[davidal66]

Gfp, right again, but isn't it completely disgusting that 'consultants' are needed to 'divine' what Zeus wants from 'up high' on their Mountain redoubt? It is a bit much. When Cortex came to the FDA with their package a month after the hold was issued, might those busy souls at the FDA have given Cortex a green to red in response to their plan? Say in late April: do another three month toxicology study and the acute stuff and you'll get a pase.

This is not science. It's a buch of civil servants with a CYA mentality. The FDA is more like some imperial court in Europe in the 17'nth century, full of intrigue, deception, and full of something else as well.

Yea, Cortex did a decent job. My frustration is towards the process at hand. I see how it is rigged towards the big boys in general and towards me-too rip off drugs like SSRI's and statins. God forbid you come up with a first-in-class drug and your a small biotech!

[gfp927z]

Daviddal, Yes, that was an anticipatory/preemptive move which turned out to be wise. BTW, do you remember if the original 3 month tox study in two species was in dogs and rats? I seem to remember that, but no longer have my original transcribed notes to verify it (only the audio tapes of the various conf calls/presentations). Thanks.

It figures that the FDA would be pricks about lifting the hold completely. On the other hand, wanting to see a second set of 3 month tox data is understandable, particularly if the original data was in dogs, and the histo "finding" was in primates.