Replies to post #19124 on RespireRx Pharmaceuticals Inc (fka RSPI)

[Aiming4]

I'm glad Cortex is being proactive about getting the data as quickly as possible.

I'll set up the survey wahjjhugo requested in #Msg-30834664 this weekend and we'll see what the board is thinking regarding the date for the 1st trial results to be PR'ed.

[alertmeipp]

>It is clear that the CRO needed more assistance from the consultants on the DSMB in its analysis so they have asked for help.

This does not sound promising at all.

[haysaw]

Be careful what you wish for Blatch-the odds are heavily against us for favorable results. Are you a pain seeker?

[enemem]

Here's my take on this letter:

"Bob, We know that the DSMB(Data Safety Monitoring Board) and the CRO are very busy crunching the data...from the standpoint of Cortex, we need to now wait until we can see results which are sufficiently complete ....The first study to be completed and analyzed will be the Parexel dose ranging study. Roger"

For whatever reason, we're going to have to wait. The company seems to intend to release the study results as they get them, rather than simultaneously. I have no experience in clinical trials, so I don't know how time-consuming the data-analysis might be. There is no advantage for them to sit on bad news if that's what they have. At least there's no press release friday evening. In fairness, this is around the very earliest we could be getting results, so the fact that we haven't heard anything yet is probably meaningless.

I'm worried sick though.

[gfp927z]

Thanks Blatch. Based on Dr. Stoll's email, it sounds like we'll probably be getting the RD-1 and RD-2 results separately, with RD-2 coming first (the dose ranging study). The study he is referring to where the DSMB is helping in the data analysis is RD-2. RD-2 is using a CRO (RD-1 isn't using a CRO, but is University based).

If the CRO and the DSMB are still crunching data, I'm figuring that getting RD-2 results next week probably isn't likely, though perhaps the following week (?) Perhaps Neuro will have a better idea on an updated timeline.

Neuro - any ideas on why the CRO asked the DSMB for assistance ("It is clear that the CRO needed more assistance from the consultants on the DSMB in its analysis so they have asked for help")? Could this be due to ambiguities / complexities in the data, the unorthodox trial design, etc? I wonder how common it is for a DSMB to be involved in the analysis of clinical trial data? Thanks.