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| 1. |
March 3, 1997 |
Original
Petition from CellPro (Request that NIH excercise march-in procedures)
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Exhibits A,
B, C,
D |
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| 2. |
March 21, 1997 |
Letter
from Dr. Wendy Baldwin to Mr. Ronald R. Peterson (Notification
to Johns Hopkins University of CellPro petition) |
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| 3. |
March 24, 1997 |
Letter
from Mr. Robert B. Lanman to Mr. Lloyd Cutler (Acknowledgment
of receipt of original petition) |
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| 4. |
April 24, 1997 |
CellPro
Supplement to Original Petition, Letter from Mssr. L Cutler and Birch
Bayh to Mr. R. Lanman (Additional comments to request) |
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Memorandum |
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Video: "Multiple
Sclerosis Patient Treated with the CEPRATE System"
(Note: Available from NIH
FOIA Office) |
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Exhibit
Volumes I and II |
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| 5. |
April 24, 1997 |
Letter
from Mr. Frederick G. Savage to Mr. R. Lanman (Confirmation of
extension until May 7 to file answer to CellPro petition) |
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| 6. |
April 29, 1997 |
Letter
from Mr. R. Lanman to Mr. L. Cutler (Re: April 24 CellPro letter)
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| 7. |
May 1, 1997 |
Note
from Ms. Barbara McGarey to Mr. Howard Califano (Re: CellPro's
supplemental submission) |
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| 8. |
May 7, 1997 |
Letter
from Mr. Donald R. Ware to Mr. R. Lanman (Re: JHU correction to
p. 28 of plaintiff's reply brief) |
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| 9. |
May 7, 1997 |
Letter
from Mr. D. Ware to Dr. W. Baldwin, Response of Johns Hopkins to CellPro's
Original Petition (Reasons to deny petition) |
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Appendix |
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Declarations
and Exhibits |
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| 10. |
May 8, 1997 |
Letter
from Mr. Gary D. Wilson to Mr. R. Lanman (Re: Baxter response) |
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| 11. |
May 12, 1997 |
Letter
from Mr. D. Ware to Mr. R. Lanman (Request for 30 day period to
respond to CellPro April 24 memorandum) |
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May 15, 1997 |
Letter
from Dr. W. Baldwin to Mr. D. Ware (Re: extension filing date
for Johns Hopkins in response to CellPro supplemental materials) |
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| 12. |
May 15, 1997 |
Letter
from William J. Marsden, Jr. to Judge Roderick R. McKelvie (Re:
Plaintiff's proposed modification to injunction) |
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Order
for Permanent Injunction and Partial Stay of Injunction |
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13.
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May 19, 1997 |
Letter
from Mr. G. Wilson to Dr. W. Baldwin (Counter-response of CellPro
to response of Johns Hopkins) |
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14.
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May 19, 1997 |
Letter
from Mr. D. Ware to Mr. R. Lanman, Declaration of Scott D. Rowley,
MD, Fred Hutchinson Cancer Research Center (Support from research
in clinical trials of Baxter Isolex systems) |
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Declaration
of Dr. Scott D. Rowley |
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| 15. |
May 20, 1997 |
Letter
from Mr. G. Wilson to Ms. Annette Hamburger (Replacement page
4) |
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| 16. |
May 27, 1997 |
Letter
from Dr. W. Baldwin to Mr. D. Ware (Re: further submissions) |
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| 17.
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May 28, 1997 |
Declaration of Larry Culver, CEO CellPro (Projected financial
performance and resulting viability of CellPro under various litigation
outcome scenarios) |
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| 18. |
May 30, 1997 |
Letter
from Mr. G. Wilson to Ms. B. McGarey (Supplement to CellPro counter-response) |
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Plaintiff's
Reply Brief in Support of Motion for a Permanent Injunction, Order
for Permanent Injunction and Partial Stay of Injunction |
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Declaration
of Dr. Bonnie Mills |
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Declaration
of Dr. James Vrednenburgh |
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Declaration
of Dr. Juan Lopez |
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Declaration
of Dr. Bo Bjorkstrand |
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Declaration
of Dr. Kenneth Cornetta |
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Declaration
of Kristen Houser |
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Declaration
of Dr. Robert A. Preti |
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Declaration
of Dr. Jerry A. Hausman |
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Transcript
of proceedings of Delaware federal district court hearings, Hopkins,
Baxter and Becton Dickinson v. CellPro, April 30, 1997 |
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| 19. |
June 2, 1997 |
Letter
from Mssr. F. Savage and D. Ware to Dr. W. Baldwin (Response to
Supplemental filing of CellPro petition) |
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Appendix |
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Exhibits |
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| 20. |
June 6, 1997 |
Letter
from Mr. G. Wilson to Ms. B. McGarey, and
Letter from Mr. Wilson to Mssr. D. Ware and F. Savage (Offer of
settlement) |
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| 21. |
June 12, 1997 |
Letter
from Mr. D. Ware to Ms. B. McGarey (Notice of letter from Baxter
to DHHS) |
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Letter
from Mr. Vernon R. Loucks to Sec. Donna Shalala (Assurance of
Baxter to protect patient care and prevent gaps in treatment) |
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| 22. |
June 13, 1997 |
Letter
from Mr. R. Lanman to Mr. D. Ware (Response to assurance of Baxter
to DHHS) |
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| 23. |
June 17, 1997 |
Letter
from Mr. D. Ware to Ms. B. McGarey (Response to declaration of
CellPro CEO Mr. L. Culver dated May 28, 1997) |
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Supplemental
Declaration of Dr. Jerry A. Hausman |
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Exhibits A-C: |
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Exhibit
A: Hambrect & Quist Spot, Report March 13, 1997 |
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Exhibit
B: CellPro Press Release, May 14, 1997 |
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Exhibit
C: Letter from Mr. D. Ware to Mr. Coe E. Bloomberg, June 10, 1997 |
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| 24. |
June 20, 1997 |
Letter
from Mr. G. Wilson to Ms. B. McGarey (Protest to acceptance of
further filings by CellPro, and request for time extension in the
alternative) |
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Letter
from Mr. D. Ware to Mr. G. Wilson dated June 20, Rejection of licensing
proposal by CellPro |
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| 25. |
June 23, 1997 |
Letter
from Mr. G. Wilson to Ms. B. McGarey (Response to letter of Mr.
Ware, dated June 20) |
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| 26. |
June 24, 1997 |
Letter
from Mr. G. Wilson to Ms. B. McGarey (Submissions to district
court) |
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Letter
from Mr. W. Marsden to Judge R. McKelvie, dated May 15, 1997 &
[Proposed] Order for Permanent Injunction and Partial Stay of Injunction,
May 15, 1997 |
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Letter
from Mr. D. Ware to Judge R. McKelvie, dated May 28, 1997, & Declaration
of Dr. Scott D. Rowley |
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Letter
from Mr. Gerard M. O'Rourke to Judge R. McKelvie, dated June 5, 1997
& following submissions to the district court: |
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Supplemental
Declaration of Dr. Monica S. Krieger |
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Declaration
of Mr. James M. Folson |
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Supplemental
Declaration of Mr. Edward Kenney |
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Letter
from Mr. D. Ware to Judge R. McKelvie, dated June 13, 1997 (Response
to letter of Mr. G. O'Rourke of June 5) |
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Supplemental
Declaration of Dr. J. Hausman |
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Letter
from Mr. Jerrold B. Reilly to Judge R. McKelvie, dated June 16, 1997 |
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Declaration
of Mr. David F. Weeda |
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| 27. |
June 24, 1997 |
Letter
from Mr. R. Lanman to Mr. D. Ware (Response to letter of Mr. Ware,
dated June 20) |
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| 28. |
June 26, 1997 |
Letter
from Mr. D. Ware to Ms. B. McGarey (Response to letter of Mr.
Wilson, dated June 23) |
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Letter
from Mr. D. Ware to Judge McKelvie, dated June 25 |
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| 29. |
July 2, 1997 |
Letter
from Mr. D Ware to Mr. R. Lanman (Response to letter of Mr. Lanman,
dated June 13) |
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| 30. |
July 2, 1997 |
Letter
from Mr. G. Wilson to Ms. B. McGarey |
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Response
of CellPro to Submissions of Johns Hopkins University and Supplement
to Original Petition of CellPro |
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Exhibits |
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| 31. |
July 3, 1997 |
Letter
from Mr. Robert D. Murdock to Dr. Myles P. Cunningham |
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Testimony
of Physicians |
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Media
Packet |
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| 32. |
July 7, 1997 |
Letter
from Mr. G. Wilson to Ms. A. Hamburger (Correction to error in
July 2 response) |
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| 33. |
July 15, 1997 |
Letter
from Mr. D. Ware to Mr. G. Wilson (Re: CellPro July 2 submission) |
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| 34. |
July 18, 1997 |
Letter
from Mr. G. Wilson to Mr. D. Ware (Response to July 15 letter) |
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| 35. |
July 22, 1997 |
Letter
from Sec. D. Shalala to Mr. V. R. Loucks |
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Enclosure:
Letter from Mr. R. Lanman to
Mr. D. Ware (Response to assurance of Baxter to DHHS) |
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Letter
from Mr. V. R. Loucks to Sec. D. Shalala (July 12) |
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| 36. |
July 24, 1997 |
Final Judgment Decision
in case of Johns Hopkins University, et. al v. CellPro, United States
District Court for the District of Delaware (1997) |
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Opinion |
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Order
for Permanent Injunction and Partial Stay of Injunction |
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Memorandum
Opinion |
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| 37. |
July 29, 1997 |
Letter
from Mr. D. Ware to Ms. B. McGarey (Re: July 2 CellPro filing
and July 24 court rulings) |
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Appendix |
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Exhibits |
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| 38. |
July 30, 1997 |
Letter
from Mr. D. Ware to Ms. B. McGarey (Re: July 28, 1997, issue of
BioCentury) |
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| 39. |
August 1, 1997 |
National
Institutes of Health, Office of the Director DETERMINATION
In the Case of PETITION OF CELLPRO, INC. Signed by Harold Varmus,
M.D., Director, NIH |
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Transcript
of FDA Biologic Response Modifiers Advisory Committee (dated Feb.
28, 1996)
Note: this is a 12.8 MB compressed file. Click
on the title for an automatic download. You will be prompted to save
it to disk. |
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Letter
from Dr. Jay Siegel to Dr. M. Krieger |
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Medical Articles |
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High-dose
chemotherapy for the treatment of breast and ovarian cancer |
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Transplantation
of the CD34+ hematopietic progenitor cells |
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Mobilization
and selection of CD34-positive hematopietc progenitors |
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High-dose chemotherapy with
stem-cell rescue for the treatment of breast cancer
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High-dose
chemotherapy with an autologous stem cell support in advanced ovarian
cancer |
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Autologous
stem cell transplantation for solid tumors in children |
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High-dose
chemotherapy with autologous stem cell rescue for breast cancer: yesterday,
today, and tomorrow |
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High-dose
therapy and autologous bone marrow transplantation in patients with
follicular lymphoma during first remission |
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A
new 'two step' procedure for 4.5 log depletion of T and B cells in
allogenic transplantation and of neoplastic cells in autologous transplantation |
