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SEC v BRITISH BIOTECH PLC, KEITH MCCULLAGH, et al Click to find out why . . .



Keywords & Phrases
CaseNo: 34-41505, Defendant: British Biotech PLC, Keith McCullagh, Peter Lewis and James Noble, Plaintiff: SEC, UniqueCaseRef: SEC>34-41505, British Biotech, Cancer Antigens, Commission, Fda, Exchange Act, Marimastat, Clinical Trials, Reports, Antigen Data, Efficacy, Mccullagh, Noble, Respondents, Lewis, Securities, Pursuant, Tumor, Violation, Measurement, Thereunder, Misleading, Antigen Levels, Disclose, Drug, United States, Effectiveness, Issuedto, Surrogate Markers, Marketing, Safety , ContentID: 120244862

Case Documents
1 1999-06-10 SEC ADMINISTRATIVE PROCEEDING
[ see first page and extracted highlights below  ] ItemID: 111598
7 pages
HTML
Total Documents: 1 document , 7 pages
Price: $ 19.95


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1 . SEC ADMINISTRATIVE PROCEEDING

EXTRACTED KEY WORDS
CANCER ANTIGENS
COMMISSION
FDA
EXCHANGE ACT
MARIMASTAT
CLINICAL TRIALS
REPORTS
ANTIGEN DATA
EFFICACY
MCCULLAGH
NOBLE
RESPONDENTS
LEWIS
SECURITIES
PURSUANT
TUMOR
VIOLATION
MEASUREMENT
THEREUNDER
MISLEADING
ANTIGEN LEVELS
DISCLOSE
DRUG
UNITED STATES
EFFECTIVENESS
ISSUEDTO
SURROGATE MARKERS
MARKETING
SAFETY
UNITED STATES OF AMERICA
Before the
SECURITIES AND EXCHANGE COMMISSION

   SECURITIES EXCHANGE ACT OF 1934
   Release No. 41505 / June 10, 1999

   ADMINISTRATIVE PROCEEDING
   File No. 3-9915

   In the Matter of

   BRITISH BIOTECH PLC,
   KEITH MCCULLAGH,
   PETER LEWIS, and
   JAMES NOBLE,
   Respondents.
   ORDER INSTITUTING CEASE-AND-
   DESIST PROCEEDINGS PURSUANT
   TO SECTION 21C OF THE
   SECURITIES EXCHANGE ACT
   OF 1934, MAKING FINDINGS AND
   ORDER OF THE COMMISSION

   I.

   The Securities and Exchange Commission ("Commission") deems it
   appropriate that public cease-and-desist proceedings be instituted
   pursuant to Section 21C of the Securities Exchange Act of 1934
   ("Exchange Act") against British Biotech PLC ("British Biotech"or
   the"Company"),Keith McCullagh ("McCullagh"), Peter Lewis ("Lewis") and
   James Noble ("Noble")(collectively, "Respondents").

   In anticipation of the institution of these administrative
   proceedings, the Respondents have submitted Offers of Settlement
   ("Offers") to the Commission,which the Commission has determined to
   accept. Solely for the purpose of these proceedings and any other
   proceedings brought by or on behalf of the Commission or in which the
   Commission is a party, and without admitting or denying the findings
   contained herein, except for those set forth below in Section II.,
   paragraphs A.1.-A.4., which are admitted, and prior to a hearing
   pursuant to the Commission's Rules of Practice, 17 C.F.R. §201.1 et
   seq., Respondents consent to the entry of the findings and he
   imposition of the order set forth below.

   Accordingly, IT IS ORDERED that proceedings pursuant to Section 21C
   be, and hereby are, instituted.

SNIPPETS:
  • SECURITIES AND EXCHANGE COMMISSION
  • BRITISH BIOTECH PLC, KEITH MCCULLAGH,
  • ORDER INSTITUTING CEASE-AND-DESIST PROCEEDINGS PURSUANT TO SECTION 21C OF THE SECURITIES
  • The Securities and Exchange Commission deems it appropriate that public cease-and-desist
  • In anticipation of the institution of these administrative proceedings, the Respondents have
  • As a foreign private issuer, British Biotech is required to file annual and current reports
  • 4.James Noble, age 39, was the Finance Director (a position essentially equivalent to the
  • During the period from November 30, 1995 through October 1996, British Biotech, through the
  • The misleading statements concerned the progress that marimastat, a British Biotech
  • In these statements, British Biotech claimed that marimastat was showing positive results in
  • The company failed to disclose, however, that from the beginning of the clinical trials, the
  • FDA regulations generallyrequire a company to conduct three phases of clinical testing to
  • Prior to the marimastat trials, however, no company had attempted to use antigen levels as
  • British Biotech claimed that marimastat was showing effectiveness in the clinical trials, rketing approval of marimastat.
  • Several months after the press release, the FDA issued the company a Notice of Violation
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