Replies to post #35634 on RespireRx Pharmaceuticals Inc (fka RSPI)

[enemem]

I'm glad it's done, but the data aren't that great. First, less than half of the subjects who got the drug showed improvement in either AHT or AHI, and there was an improvement in blood gas variables (it's unclear if these numbers are for everybody or for a subgroup).

The problem here is that the subjects who took the drug slept less. This is the most robust finding of the study (p<0.001).

What we have here is a drug that marginally reduces apnea, but robustly reduces sleep, a problem that I foresaw at the very start of this adventure.

I hope that the market reacts favorably. Whatever the reaction, I am glad this is behind us. I am curious about whether others think these results are consistent with a partnerable indication.

[haysaw]

Wow CHM-How did you retrieve the release? I still don't see anything on Yahoo Finance or Corx home page.

Well, what do you guys think? The results seem to be all over the place--hard to interpret what value the market will place on the info. I can't imagine how Corx mngmnt will be able to sell this mixed bag going forward. One concretely good thing: The safety profile did not include any surprises.

[jerrydylan]

I don't know how to respond to this other than to say the drugs clearly have an effect on the central nervous system, some effect on SA, RD very likely, and the sleep reduction is symbiotic with an effect on attention deficits one can guess- do not at all seem like a dead end. With folks like Pfizer continuing to slash and burn RD it's anyone's guess if there are willing partners but I think CX-1739 and AMPA deserves a chance.

[neuroinv]

Certainly a mixed bag:
1) It looks like overall oxygenation was improved in CX1739 patients
2) It looks like three patients hit the prespecified responder endpoints for both AHI and AHT (this is assuming the two groups overlapped, which seems likely, but isn't clear from the press release--at least five hit one or the other.)
3) The long delay had left me guessing that there were some responders--and if this is replicable, providing improvement in 31% of the sleep apnea population, for whom there is no oral therapy--it would not be insignificant. Potentially millions of users.
4) The two caveats are: Can they prospectively identify the likely responders? My expectation about the delay was that this was the goal, sorting out which patients responded and why. If they figured any of that out, it is not in the PR. It might be too small a sample to draw any confident conclusions. Secondly--as Enemem had predicted, the negative effect on sleep itself, even if vigilance remains the same. Can it be moderated via lower dosing, given over time? Does the overall net effect show benefit, especially (as Athero noted) in cv functioning? That will take a larger and longer-duration trial.

Overall, the results suggest that an Ampakine can produce some benefit for a large group of SA patients. Whether this is the right dose, or the right Ampakine, and for which patients--that has yet to be established.

Does this make SA itself a partnerable indication? I'm not that optimistic, these results produce a lot more questions than most pharmas want to see when deciding on an inlicensing. More likely if combined with RD, which they can hopefully get back from Valeant. Valeant has been distracted by a $480 million Swiss generics acquisition, so RD has not been at the top of their BusDev menu.

The data are a reminder of the Ampakine effects on alertness/vigilance that speak to the ADHD indication. Certainly if Cortex were to select the #1 priority based on everything they now know, ADHD would stay at the top of the list.


NeuroInvestment

[enemem]

To beat a dead horse here one more time, the top of line results of CX1739 involved 4 variables. A good statistician could have pulled those results out in an afternoon. The parameters that were looked at were obvious ones, and would have been defined ahead of time as a short list of outcome variables to extract. Thus the notion that intensive post-hoc analysis allowed world-class statisticians to extract some counter-intuitive signal seems ridiculous.

There may have been plenty of other analyses that needed to be explored, but these top-of-line results could have been released in September, within a week of the last patient's data being logged. We'd be in a better situation now if they had presented the top-of-line findings promptly, as they were supposed to.

My take on this: they blundered into the wrong indication, completely mishandled communications about why the trial, which was to take 6 months ended up taking 2 years, and then appeared to sit on the trial outcome for 4 months.

Corx management has demonstrated a lack of strategic vision, ethics and competence. Bad luck has little to do with our predicament.

I need to get out of this stupid stock. At this point, I find it impossible to realistically see a path to profitability for this company because the people running it completely lack judgement.

My difficulty is to accept that I have wiped out a substantial part of my savings, and move on. This is emotionally very difficult.