CellPro March-In Petition Documents

First-Party Correspondence Documents

Electronic and hardcopies of the following documents are available from the NIH FOIA Office:

Date Document
1. March 3, 1997 Original Petition from CellPro (Request that NIH excercise march-in procedures)
  • Exhibits A, B, C, D
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
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
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
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
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
19. June 2, 1997 Letter from Mssr. F. Savage and D. Ware to Dr. W. Baldwin (Response to Supplemental filing of CellPro petition)
  • Appendix
  • Exhibits
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)
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
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
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
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
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
31. July 3, 1997 Letter from Mr. Robert D. Murdock to Dr. Myles P. Cunningham
  • Testimony of Physicians
  • Media Packet
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)
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
37. July 29, 1997 Letter from Mr. D. Ware to Ms. B. McGarey (Re: July 2 CellPro filing and July 24 court rulings)
  • Appendix
  • Exhibits
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

Third-Party Correspondence Documents

These documents are available from the NIH FOIA Office.

This page last reviewed on September 11, 2015