First-Party Correspondence Documents
Electronic and hardcopies of the following documents are available
from the NIH
FOIA Office:
1. March 3, 1997 |
Original Petition from CellPro (Request
that NIH excercise march-in procedures)
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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) |
3. March 24, 1997 |
Letter from Mr. Robert B. Lanman
to Mr. Lloyd Cutler (Acknowledgment of receipt of original
petition) |
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)
- Memorandum
- Video: "Multiple Sclerosis Patient Treated with the
CEPRATE System"
(Note: Available from NIH FOIA Office)
- 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) |
6. April 29, 1997 |
Letter from Mr. R. Lanman to Mr. L. Cutler (Re: April 24
CellPro letter) |
7. May 1, 1997 |
Note from Ms. Barbara McGarey to
Mr. Howard Califano (Re: CellPro's supplemental submission) |
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) |
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)
- Appendix
- Declarations and Exhibits
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10. May 8, 1997 |
Letter from Mr. Gary D. Wilson to
Mr. R. Lanman (Re: Baxter response) |
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) |
11. 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) |
12. May 15, 1997 |
Letter from William J. Marsden,
Jr. to Judge Roderick R. McKelvie (Re: Plaintiff's proposed
modification to injunction)
- Order for Permanent Injunction and Partial Stay of
Injunction
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13. May 19, 1997 |
Letter from Mr. G. Wilson to Dr.
W. Baldwin (Counter-response of CellPro to response of Johns
Hopkins) |
14. 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)
- 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) |
16. May 27, 1997 |
Letter from Dr. W. Baldwin to Mr.
D. Ware (Re: further submissions) |
17. May 28, 1997 |
Declaration of Larry Culver, CEO
CellPro (Projected financial performance and resulting viability
of CellPro under various litigation outcome scenarios) |
18. May 30, 1997 |
Letter from Mr. G. Wilson to Ms.
B. McGarey (Supplement to CellPro counter-response)
- Plaintiff's Reply Brief in Support of Motion for a
Permanent Injunction, Order for Permanent Injunction
and Partial Stay of Injunction
- Declaration of Dr. Bonnie Mills
- Declaration of Dr. James Vrednenburgh
- Declaration of Dr. Juan Lopez
- Declaration of Dr. Bo Bjorkstrand
- Declaration of Dr. Kenneth Cornetta
- Declaration of Kristen Houser
- Declaration of Dr. Robert A. Preti
- Declaration of Dr. Jerry A. Hausman
- 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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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) |
21. June 12, 1997 |
Letter from Mr. D. Ware to Ms. B.
McGarey (Notice of letter from Baxter to DHHS)
- 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) |
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)
- Supplemental Declaration of Dr. Jerry A. Hausman
- Exhibits A-C:
- Exhibit A: Hambrect & Quist Spot, Report March 13,
1997
- Exhibit B: CellPro Press Release, May 14, 1997
- 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)
- 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) |
26. June 24, 1997 |
Letter from Mr. G. Wilson to Ms.
B. McGarey (Submissions to district court)
- 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
- Letter from Mr. D. Ware to Judge R. McKelvie, dated
May 28, 1997, & Declaration of Dr. Scott D. Rowley
- Letter from Mr. Gerard M. O'Rourke to Judge R. McKelvie,
dated June 5, 1997 & following submissions to the district
court:
- Supplemental Declaration of Dr. Monica S. Krieger
- Declaration of Mr. James M. Folson
- Supplemental Declaration of Mr. Edward Kenney
- Letter from Mr. D. Ware to Judge R. McKelvie, dated
June 13, 1997 (Response to letter of Mr. G. O'Rourke
of June 5)
- Supplemental Declaration of Dr. J. Hausman
- Letter from Mr. Jerrold B. Reilly to Judge R. McKelvie,
dated June 16, 1997
- 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) |
28. June 26, 1997 |
Letter from Mr. D. Ware to Ms. B.
McGarey (Response to letter of Mr. Wilson, dated June 23)
- 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) |
30. July 2, 1997 |
Letter from Mr. G. Wilson to Ms.
B. McGarey
- Response of CellPro to Submissions of Johns Hopkins
University and Supplement to Original Petition of CellPro
- Exhibits
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31. July 3, 1997 |
Letter from Mr. Robert D. Murdock
to Dr. Myles P. Cunningham
- Testimony of Physicians
- 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) |
33. July 15, 1997 |
Letter from Mr. D. Ware to Mr. G.
Wilson (Re: CellPro July 2 submission) |
34. July 18, 1997 |
Letter from Mr. G. Wilson to Mr.
D. Ware (Response to July 15 letter) |
35. July 22, 1997 |
Letter from Sec. D. Shalala to Mr.
V. R. Loucks
- Enclosure: Letter from Mr. R. Lanman to Mr. D. Ware
(Response to assurance of Baxter to DHHS)
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)
- Opinion
- Order for Permanent Injunction and Partial Stay of
Injunction
- 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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38. July 30, 1997 |
Letter from Mr. D. Ware to Ms. B.
McGarey (Re: July 28, 1997, issue of BioCentury) |
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
- Transcript of FDA Biologic Response Modifiers Advisory
Committee (dated Feb. 28, 1996)
- Letter from Dr. Jay Siegel to Dr. M. Krieger
- Medical Articles
- High-dose chemotherapy for the treatment of breast
and ovarian cancer
- Transplantation of the CD34+ hematopietic progenitor
cells
- Mobilization and selection of CD34-positive hematopietc
progenitors
- High-dose chemotherapy with stem-cell rescue for
the treatment of breast cancer
- High-dose chemotherapy with an autologous stem cell
support in advanced ovarian cancer
- Autologous stem cell transplantation for solid tumors
in children
- High-dose chemotherapy with autologous stem cell
rescue for breast cancer: yesterday, today, and tomorrow
- High-dose therapy and autologous bone marrow transplantation
in patients with follicular lymphoma during first remission
- 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
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Third-Party Correspondence Documents
These documents are available from the NIH
FOIA Office.
This page was last reviewed on
April 3, 2008
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