|
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 ยง 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.
|
__________________
2/6/09 Core needle biopsy: negative; Mammos through 2010: no change
3/30/11 Pea-sized lump in left breast at site of prior biopsy; mammo negative, sonogram not so much
4/14/11 Core needle biopsy: negative for cancer
5/18/11 Excisional biopsy 1.2 cm tumor, LVI, positive margin; ER+60%,PR+20%,HER2/CEP17 5
6/15/11 BMX: Left DCIS & LH; Right ADH; SNB: 2/3 nodes: 1.4 cm and 1 mm; ALND L1&2: 0/10; Stage IIa, Grade 3
7/14/11 CT/Bone scans NED; MUGA 66%
7/19/11 Biweekly dd AC w/Neulasta; done 8/30/11
9/13/11 Transfusion (Hemoglobin 8.6); MUGA 64%
9/20/11 Start Taxol + Herceptin; Taxol done 12/6/2011; continue Herceptin until 9/4/2012
12/27/11 Radiation - 6 weeks; 2/27/2012 - DONE! Yayyyy!
2/29/12 Start Tamoxifen 20 mg/day; continue until 2/28/17
5/16/12 Start five-years Metformin trial
6/19/12 MUGA 61%
8/21/12 Brain MRI NED (head still hurts, brain still fogged)
9/4/12 Herceptin done!
9/6/12 Port out!
7/11/13 Aricept 5mg for cognitive impairment; increased to 10mg as of 8/23/13; back to 5mg 12/2013
5/2014 Add Namenda 7mg
9/2014 Stop Aricept and Namenda; Neuropsychological evaluation
10/24/14 Start cognitive rehabilitation therapy
|
Re: Sign Petition to Stop Delay of the GP2 Vaccine
Hybrid Mode
