RespireRx Pharmaceuticals Inc (RSPI)

[neuroinv]

OT: VANDA
I certainly wasn't predicting approval, but I don't think it has anything to do with the CNTF biomarker. This is what I wrote about that marker two months ago:
<<Based on the data thus far, iloperidone appears to be very similar to Geodon in all respects, other than it appears more prone to rare but worrisome QTc outliers, patients with more pronounced QTc changes, and less prone to akathisia. Vanda’s aspiration to genomically steer likely responders towards iloperidone has not come to pass: The only test that is operational assesses the presence of two versus one intact CNTF-expressing (Ciliary Neurotrophic Factor gene) genes, and thereby parses out the 75% of patients with two intact copies, who are more likely to respond to atypicals (including but no limited to iloperidone) from the 25% with one intact copy, who are treatment-responsive, but not as much. That genomic test is useless in its current form.>>

Last year Polymeropoulos said on a quarterly call that they had never tested users of other antipsychotic drugs on that test in comparison to iloperidone users--saying that they would leave that to a partner. Hence my conclusion that this test has, at present, virtually no discriminating power, and would not affect treatment planning one bit. If they subsequently ran trials comparing antipsychotics to demonstrate some differentiation, I missed it, but I don't think that occurred.

Maybe it was the less akasthisia, maybe--I don't know. It's a real surprise to me, because the FDA had asked them to do another trial (my memory was it was another Risperdal comparator trial), they balked, and yet they received approval. How often does that happen?

Damn. I knew I should have put all my worldly possessions into Vanda stock today.

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