RespireRx Pharmaceuticals Inc (fka RSPI)

[davidal66]

My take . . . not such a binary event after all=).

Cortex wins, but with some 'makeup work.' The key concerns of the FDA are relieved tot he point the hold is lifted, but the company must complete another round of three month toxicology studies--to confirm their 'acute' testing clean profile. The three month histology repeat is well underway from the PR.

So, it looks like Cortex can restart their Alzheimer's trial--two dosages 300 at one dose and 1000 mg at one dose--one day.

They were running a PK test for phase IIb when the hold was issued so that can be completed.

They can perform another ADHD test. If the FDA decision means Cortex must wait for a month or two to proceed with an ultra-high dose test, then why not testing the hypothesis that 800mg or 1000mg once a day in ADHD might be effective over 21 days.

At any rate, a good day. One could argue, CX717 has been put through a tough journey with primates, rats and other models with a stellar safety profile; this was also seen in man--young and old, in a broad range of dosages--high and low.

Cortex can also resume their large partner negotiations as well.