Boston Life Sciences to Meet with FDA to Discuss Approval of Therafectin

Strategic Insights -

Boston Life Sciences, Inc. is set to meet with the FDA in the first quarter of 2000 to discuss its application for the approval of Therafectin, a drug for the treatment of rheumatoid arthritis. The company submitted a letter to the FDA in response to the agency's request for additional information, citing the lack of sufficient evidence of a statistically significant treatment effect in its trial for the drug. The FDA has granted the company a full opportunity to learn the specific basis of their position on efficacy and what could be done to possibly gain approval for Therafectin.

Key Takeaways:

  • Boston Life Sciences is meeting with the FDA in the first quarter of 2000 to discuss the approval of Therafectin, a drug for the treatment of rheumatoid arthritis.
  • The FDA has cited the lack of sufficient evidence of a statistically significant treatment effect in Boston Life Sciences' trial for Therafectin as the reason for not approving the drug.
  • The company has been granted a full opportunity to learn the specific basis of the FDA's position on efficacy and what could be done to possibly gain approval for Therafectin.
  • Boston Life Sciences is developing novel treatments for cancer, autoimmune diseases, and central nervous system disorders, including Therafectin, Altropane, Troponin I, AF-1, Inosine, and transcription factors.
  • The company expects to incur no further material expenditures in connection with Therafectin, with total expenditures to date totaling less than $1.5 million.
  • Boston Life Sciences has approximately $16 million in cash resources, sufficient to support its primary programs well into 2001.

Statistics:

  • $1.5 million: Total expenditures by Boston Life Sciences on Therafectin since 1995.
  • $16 million: Cash resources available to support Boston Life Sciences' primary programs as of December 31, 1999.
  • 1998: Year in which Boston Life Sciences submitted the results of its latest Phase III trial for Therafectin to the FDA.
  • 1999: Year in which the FDA informed Boston Life Sciences that it would not approve Therafectin due to lack of sufficient evidence of a statistically significant treatment effect.
  • 2000: Year in which Boston Life Sciences is expected to meet with the FDA to discuss the approval of Therafectin.
  • First Quarter 2000: Timeframe in which Boston Life Sciences is set to meet with the FDA to discuss the approval of Therafectin.

Sources:

  • Business/Technology Editors & Health/Medical Writers, Boston Life Sciences, Inc., "Boston Life Sciences to Meet with FDA to Discuss Approval of Therafectin" (BW HealthWire), December 29, 1999.
  • Boston Life Sciences, Inc., "Boston Life Sciences to Meet with FDA to Discuss Approval of Therafectin" (Press Release), December 29, 1999.
  • Boston Life Sciences, Inc., "Boston Life Sciences to Meet with FDA to Discuss Approval of Therafectin" (Annual Report on Form 10-K/A), 1999.