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Old 12-16-2014, 11:09 AM   #20
rhondalea
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Join Date: Jun 2011
Location: Somerset, NJ
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Note to Phil: I just realized that when I uploaded the order, I forgot to run text recognition. It's fixed now, so if you need to copy and paste from it, you won't have a problem.

On the GP2 trial:

https://www.clinicaltrials.gov/ct2/s...erm=gp2&rank=1

I don't think clinicaltrials.gov tells the whole story. Recruiting was terminated prematurely (pages 17-25 of the order). The order assigns responsibility for trial completion to Norwell if Norwell so chooses. Of course, pending the appeal, the trial is funded with vapor--there is no money. Here's the relevant paragraph at the end of that section:

Quote:
Since we have determined that the enrollment requirements of the May 7, 2009 agreement have not been met [emphasis supplied], and since HJF has not notified the Panel that it would do so after receiving the objection of Norwell, it would be unfair to require Norwell to continue to pay HJF under the License Agreement to fund the GP2 clinical trial for further enrollment which may now be undertaken by Norwell. Therefore, Norwell will be relieved of its Clinical Trial Financial Support obligation under 3.6 of the License Agreement and any unpaid delay fees under Section 17 of the First Amendment and Section 5 of the Second Amendment. Norwell will be free to pursue the GP2 clinical trial on an independent basis.
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