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geocappy1

04/01/14 8:37 AM

#170840 RE: Frustrated #170839

Yes, maybe you missed it was an IST and up til now they have let the Investigator do the communicating.
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Protector

04/01/14 9:02 AM

#170847 RE: Frustrated #170839

Frustrated, No you didn't miss it.

1) PPHM said they'll start the trial

2) PPHM didn't say they'll PR it but they might although I think they'll mention this at AACR in 4 days rather then sending out a PR this week (we'll see)

3) If PPHM would choose the way of a PR they will refer to the clinicaltrials.gov and the clinical trial number. If they started the trial YESTERDAY (last day of March like they started PIII NSCLC also last day of a month (DEC)) then clinicaltrilas.gov will NOT be updated. CT.gov updates tomorrow which will make all changes to the trial For 30th (partially), 31th MAR, 1th, 2nd APR visible. (you can check at the end of page were this last update date is listed, you'll see that it currently says 30th MAR, meaning the update of 30th MAR made after 6AM Eastern are NOT yet visible either)). It is not good practice to PR with a link to a NOT up to date page that would say "not recruiting yet".

I know about the time because I checked this new trial and the NSCLC every day several times and so found out when they run the updates as this happens around my noon, US Eastern early morning. That is why you see cheynew beat me on posting the clinical trial updates on IHub because those FDA bastards update often during my lunch time :)

So if the next update is run tomorrow and Thursday morning we do not see it in the CT.gov as "recruiting" then it is possible that PPHM kept it specifically as news they'll combine with ACCR. For this fact they are under no 4 day SEC listing obligation so they can fit the news where they think it gets best exposure or not even PR it at all. The ct.gov however MUST be updated if they start it.

If however we don't see it started when AACR is done then you can say PPHM (KING) did not keep his precise timing indication :)

If on the other hand they would have delayed the trial or think about cancelling it because of what has been made public about BMY's Yervoy (that apparently kills people according what was posted, although I think DD remark about the silliness of that news makes sense) then we may see a totally different PR or find out via a general update PR they cancelled it. That would then be due to a development of events that are not under their control.

I am always supportive of a change of plans for good reasons that developed after the plan was made. I think it is good management. However I have NO indication that this trial would be cancelled, on the contrary I still seek confirmation about the starting of a second such trial this year (as per what Dr Brekken MAY (MAY) have said at NYAS - it could have been misunderstanding too)..