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Old 12-16-2014, 11:29 AM   #21
europa
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

I'm going in Feb for my booster and draw. My nurse said everything is running normally
__________________
DX 10/2011
PET Scan + MRI 10/2011
Lumpectomy 11/11/11
Stage 2B +++ ER+(10%), PR+(5%), HER2+++(1 positive node, 1 micromets to second node)
AC started 12/2011 ended 1/2012
Taxol + Herceptin weekly for 12 weeks ended 4/2012
30 zaps of radiation done 6/2012
Tamoxifen 6/2012
every 3 weeks of Herceptin for another year.
Metformin Trial 8/12
10/12 MRI- CLEAR
01/13 BRAIN MRI- CLEAR!
01/13 Neck MRI- CLEAR!
FINISHED HERCEPTIN 1/9/2013...Woot Woot
Starting Walter Reed Vaccine Trial 2/13
CT Scans + ultrasound of abdomen CLEAR-5/13
02/2015 through 11/2015 emergency D&Cs for Tamoxifen induced uterine polyps which caused uncontrollable hemorrhaging
12/2015 blood clot to left leg caused by Tamoxifen. No longer taking it. On Xarelto, a blood thinner
12/2015 Ablation to prevent hemorrhaging from potential issues with Tamoxifen residue in my system
1/2016 continuing journey without hormonal therapy. Reevaluating the option of a hysterectomy and oopherectomy.

www.mychemobag.org
www.facebook.com/mychemobag

6 YEARS NED
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Old 12-16-2014, 11:59 AM   #22
rhondalea
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

I hope it stays that way for the patients who are enrolled. It may be there were sufficient supplies to cover those who were in the program. It may also be that there is action behind the scenes to keep things running for the current enrollees until the court decides or there is a settlement. But the order isn't just an order or a history of the case, it's also a history of the vaccine trial itself, and until this is settled, GP2 is limping.
__________________

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
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Old 12-16-2014, 01:06 PM   #23
'lizbeth
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Europa,

Sounds like much ado about nothing. It hasn't affected me in the clinical trial. I enrolled after the lawsuit and did the entire trial.

I doubt that this has much to do with the GP2 trial.
I'm sure this ties back to the discussion about the KRAS variant. I had no idea it would stir up such a ta-do. I was just sharing information that I hoped would advance standard of care.

Post all you want. The GP vaccine trial is moving forward despite the postings. Happy to have participated.

Last edited by StephN; 01-07-2015 at 11:45 AM.. Reason: Soften the discourse.
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Old 12-16-2014, 01:23 PM   #24
rhondalea
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

For the record, Phil did not participate in the discussion of the KRAS-variant study, and I doubt he even followed the thread, because it's not his area of interest.

I first heard about this petition on the Facebook site, so I logged into PACER, downloaded the order and the current appellate docket, and I made them available to anyone who had an interest in a more detailed understanding of the current status of the GP2 vaccine.

For myself, I do not care about the vaccine because I am not a trial participant. For those who want an opportunity to try the vaccine, I care deeply, which is why I signed the petition, even though I'm not confident it will help given the amount of money at stake in the litigation.

This is the second time you've made a totally baseless accusation about my motivations, 'lizbeth. Don't do it again.
__________________

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
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Old 12-16-2014, 06:01 PM   #25
europa
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

I think that every participating hospital received enough supplies for the number of participants to complete Phase II. That is what I was told. The only thing that gets sent out to Walter Reed is blood to see how people are responding to the vaccine.
I do know that my hospital has yet to hear if there will be a phase III. Looks like that part is kind of in limbo. The whole situation sounds sad and completely bureaucratic to me. But thankfully those that are enrolled will continue to benefit from the phase II.
__________________
DX 10/2011
PET Scan + MRI 10/2011
Lumpectomy 11/11/11
Stage 2B +++ ER+(10%), PR+(5%), HER2+++(1 positive node, 1 micromets to second node)
AC started 12/2011 ended 1/2012
Taxol + Herceptin weekly for 12 weeks ended 4/2012
30 zaps of radiation done 6/2012
Tamoxifen 6/2012
every 3 weeks of Herceptin for another year.
Metformin Trial 8/12
10/12 MRI- CLEAR
01/13 BRAIN MRI- CLEAR!
01/13 Neck MRI- CLEAR!
FINISHED HERCEPTIN 1/9/2013...Woot Woot
Starting Walter Reed Vaccine Trial 2/13
CT Scans + ultrasound of abdomen CLEAR-5/13
02/2015 through 11/2015 emergency D&Cs for Tamoxifen induced uterine polyps which caused uncontrollable hemorrhaging
12/2015 blood clot to left leg caused by Tamoxifen. No longer taking it. On Xarelto, a blood thinner
12/2015 Ablation to prevent hemorrhaging from potential issues with Tamoxifen residue in my system
1/2016 continuing journey without hormonal therapy. Reevaluating the option of a hysterectomy and oopherectomy.

www.mychemobag.org
www.facebook.com/mychemobag

6 YEARS NED
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Old 12-16-2014, 06:37 PM   #26
rhondalea
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

That makes sense, europa. The hospital where I'm doing the metformin study has a closet full of five years' worth of giant pill bottles.

Norwell won't be in a position to put anything into play until it has all the documentation from the HJF, but the language of the arbitration award indicates it is eager to forge ahead with GP2 research. I have no idea how Norwell will deal with the premature termination of recruiting in Phase II, but the sooner the case is settled, the sooner it can patch the holes and get on with the research. Then it will be onward to Phase III.
__________________

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

Last edited by rhondalea; 12-17-2014 at 02:03 PM.. Reason: transposition
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Old 12-17-2014, 01:48 PM   #27
phil
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

thanks for confirmation that enrollment requirements were not met , and i have heard that hjf still has data paperwork that norwell needs . . all info that should be looked into - i am neither pro norwell nor anti - hjf/dr p. - but pro - stage iv pt. none of these entities have the sense of urgency that stage iv requires - their lack of urgency is nothing personal , just their timetable is not ours. if they had an immediate family mbr w/ strong her2 overexpression - at dx or metastatic - they would be pushing for as quick a process as possible.
i dont think you have to fill very slot to move on to phase III, hopefully these entities wil settle and get going on to next phase .
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Old 12-27-2014, 09:20 PM   #28
Dakini52
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Signed. Thanks Phil.
__________________
Diagnosed June, 2006 HER2+++, ER- PR-, Grade 3, Stage IIB. Modified radical mastectomy, radiation, chemo, Herceptin, Tykerb 1 year. [*]In remission until 2/2010. Small tumor detected on chest wall during routine scan. 2/2010 surgery to remove tumor, started Herceptin/Tykerb, follow up radiation. [*]12/26/2010 - Off Tykerb due to allergic reaction[*]12/16/2014 - Have continued on Herception for almost 5 years now and remain NED. Discussion with onc re adding Perjeta to the Herceptin as another way of preventing recurrence. Still in discussion phase. 12/26/14 Onc applying for approval for Perjeta.
Perjeta approved and I received one infusion. It had an immediate impact to my lungs and I experienced difficulty breathing so.....I'm going to be sticking with just Herceptin. Still looking for a good vaccine program to enroll in.

Debbie K
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Old 12-28-2014, 09:48 AM   #29
Catia
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

I too am a participant in the GP2 vaccine trial and have been told to continue to come (last month and again in April 2015) to complete my booster shots. I was also aware that down at MD Anderson they did fill all the slots for their portion of the trial...that being said, I am not sure about the legal responsibilities of studies to continue with the enrolled subjects once they have started?

I strongly feel that there are different ways to advocate. Whether you try to enroll yourself to contribute and move studies along or whether you raise awareness and organize to be heard or put pressure on companies or the public are just different ways to go about it. I think we all want the same in the end: A cure and access for all to get it!
I think you all are such effective and strong resource to all of us,...keep up the fight on ALL levels and thank you!
__________________
Dx: April1st (yes April Fool's Day!), 2011
ER-/PR-/HER2+++ Tumor grade 3 size:1.6mmx1.2mm
Micromet to sentinel node, 5 auxiliary nodes were clear, stage 1B
April 13th, 2011 Double Mastectomy, no immediate reconstruction
May 2011 to Nov, 2011 chemo AC-TH plus
Herceptin until Sep 2012
11/2012 Began GP-2 vaccine at MD Anderson in Houston (monthly shots until April 2013), now receiving booster shots every six months
Began natural breast reconstruction with BRAVA procedure in Oct 2012
Oct 2012 First fat graft
Jan 2013 Second fat graft
March 2013 Third fat graft
July 2013 Final touch-up with nipple reconstruction
November 2013: Vaccine Booster #1
January 2014 Nipple tatooing
April 2014: Vaccine Booster #2
October 2014: Vaccine Booster #3
April 2015: Vaccine Booster #4 (trial finished)
Dec 2015: Scar treatment with Kenalog and laser
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Old 12-28-2014, 01:44 PM   #30
Dakini52
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Smile Re: Sign Petition to Stop Delay of the GP2 Vaccine

Wow Carol Ann, as long as I've been a member I didn't know there was a Facebook page. Just asked to become a member of the group. Can anyone explain what this lawsuit is about?
__________________
Diagnosed June, 2006 HER2+++, ER- PR-, Grade 3, Stage IIB. Modified radical mastectomy, radiation, chemo, Herceptin, Tykerb 1 year. [*]In remission until 2/2010. Small tumor detected on chest wall during routine scan. 2/2010 surgery to remove tumor, started Herceptin/Tykerb, follow up radiation. [*]12/26/2010 - Off Tykerb due to allergic reaction[*]12/16/2014 - Have continued on Herception for almost 5 years now and remain NED. Discussion with onc re adding Perjeta to the Herceptin as another way of preventing recurrence. Still in discussion phase. 12/26/14 Onc applying for approval for Perjeta.
Perjeta approved and I received one infusion. It had an immediate impact to my lungs and I experienced difficulty breathing so.....I'm going to be sticking with just Herceptin. Still looking for a good vaccine program to enroll in.

Debbie K
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Old 12-28-2014, 03:48 PM   #31
rhondalea
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

I'm not Carol Ann, but...

The Facebook page is new. europa started it the last time this site went down for several days so we'd all have somewhere to go if it happened again. Anyone else who is interested and who hasn't seen the post about it can look it up on Facebook with "Her2support." Currently, there are 84 members.

As for explaining the lawsuit, it might make more sense if you read the original order linked in an earlier thread. The bottom line is an agreement that didn't work out quite as anyone planned, followed by a disagreement about who owes what to whom. For details, though, the order is the best source.
__________________

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
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Old 01-09-2015, 12:09 PM   #32
phil
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Norwell won the appeal ! The Federal Appeals Court threw out the Henry " Scoop " Jackson Foundations' appeal in very succinct fashion . Now we will see if HJF will expeditiously turn over the data to Norwell so the Phase III trial can begin : http://www.ca4.uscourts.gov/Opinions...d/141580.U.pdf
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Old 01-09-2015, 04:44 PM   #33
sassy
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Great news Phil!!!!!

Keep up the good work!
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Rhonda (Sassy)
dx age 45
DX 2/15/05 Stage IIb (at surgery)restaged IIIa
Left mast .9cm tumor 5 of 14 nodes
Triple Positive
4 DD A/C
12 Taxol/Herceptin
33Rads
Strange infect mast site one year aft surg, hosp 1 wk
Herceptin for total of 18 months
Lupron Monthly 4 yrs
Neurontin for aches, pains and hot flashes(It works!)
Ovaries removed 11/09 stop Lupron and Neurontin
Arimidex 6 yrs (tried Femara, no SE improvement)
Tried Exemestane-hips got so bad could hardly walk
Back to Arimidex for year seven
Zometa 2X Annual for 7years, Lasix
Stop Arimidex 5/13
Stop Zometa 7/13-Bi-lateral Stress Fractures in Femurs from Zometa
5/14 Start Tamoxifen
3/15 Stem cell transplant to stimulate femur bone growth/healing
5/15 Complete fracture of right femur/Titanium rods both femurs
9/16 Start Evista stopTamoxifen
13 YEARS NED!
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Old 01-09-2015, 06:35 PM   #34
Dakini52
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

fyi - just saw this on another blog and thought I would pass it along. good news for the GP2 vaccine? http://www.ca4.uscourts.gov/Opinions...d/141580.U.pdf
__________________
Diagnosed June, 2006 HER2+++, ER- PR-, Grade 3, Stage IIB. Modified radical mastectomy, radiation, chemo, Herceptin, Tykerb 1 year. [*]In remission until 2/2010. Small tumor detected on chest wall during routine scan. 2/2010 surgery to remove tumor, started Herceptin/Tykerb, follow up radiation. [*]12/26/2010 - Off Tykerb due to allergic reaction[*]12/16/2014 - Have continued on Herception for almost 5 years now and remain NED. Discussion with onc re adding Perjeta to the Herceptin as another way of preventing recurrence. Still in discussion phase. 12/26/14 Onc applying for approval for Perjeta.
Perjeta approved and I received one infusion. It had an immediate impact to my lungs and I experienced difficulty breathing so.....I'm going to be sticking with just Herceptin. Still looking for a good vaccine program to enroll in.

Debbie K
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Old 01-09-2015, 09:24 PM   #35
Dakini52
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Wanted to clarify that the previous post refers to the court decision in favor of Norwell on 1/8/15 :-)
__________________
Diagnosed June, 2006 HER2+++, ER- PR-, Grade 3, Stage IIB. Modified radical mastectomy, radiation, chemo, Herceptin, Tykerb 1 year. [*]In remission until 2/2010. Small tumor detected on chest wall during routine scan. 2/2010 surgery to remove tumor, started Herceptin/Tykerb, follow up radiation. [*]12/26/2010 - Off Tykerb due to allergic reaction[*]12/16/2014 - Have continued on Herception for almost 5 years now and remain NED. Discussion with onc re adding Perjeta to the Herceptin as another way of preventing recurrence. Still in discussion phase. 12/26/14 Onc applying for approval for Perjeta.
Perjeta approved and I received one infusion. It had an immediate impact to my lungs and I experienced difficulty breathing so.....I'm going to be sticking with just Herceptin. Still looking for a good vaccine program to enroll in.

Debbie K
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Old 01-12-2015, 03:19 AM   #36
donocco
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

Signed

Paul
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Old 02-09-2015, 10:13 AM   #37
Rosalie
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

I am trying to contact Norwell directly about this to try and get new info. I can't find them online though, which is very weird. Does anyone know the best way to reach them?
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Old 02-10-2015, 09:35 AM   #38
phil
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

last I heard , after losing 2 court cases , HJF was still dragging out turning over data , and Dr. P is gone to Galena Pharma. will update when I get more info.
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Old 02-10-2015, 03:47 PM   #39
Rosalie
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Re: Sign Petition to Stop Delay of the GP2 Vaccine

That's the last I heard too but it looks as is Norwell is no longer in business from the research I've done: http://www.corporationwiki.com/Texas.../39290919.aspx
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