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Exelixis, Inc. Message Board

  • xwavve xwavve Apr 10, 2013 8:09 PM Flag

    FDA Breakthrough Definition - Does EXEL Merit?

    What is breakthrough therapy designation?

    Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A breakthrough therapy designation conveys all of the fast track program features (see below for more details on fast track designation), as well as more intensive FDA guidance on an efficient drug development program. The FDA also has an organizational commitment to involve senior management in such guidance. Section 902 of FDASIA requires the following actions, as appropriate: holding meetings with the sponsor and the review team throughout the development of the drug providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment assigning a cross-disciplinary project lead for the FDA review team to facilitate an efficient review of the development program and to serve as a scientific liaison between the cross-discipline members of the review team (i.e., clinical, pharmacology-toxicology, chemistry, manufacturing and control (CMC), compliance) for coordinated internal interactions and communications with the sponsor through the review division’s Regulatory Health Project Manager involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review.....

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      "Section 902 of FDASIA requires the following actions, as appropriate: holding meetings with the sponsor and the review team throughout the development of the drug providing timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable taking steps to ensure that the design of the clinical trials is as efficient as practicable"

      I actually figured this to be the reason for the pronounced CRADA/CTEP presence in Cabo's development.
      Let there be no dispute about it. Cabo is advanced therapy, and the Feds will eventually need to step up to the plate and either advance it - or lend reason why. It's a matter of time. JMHO - but I suspect BP will intervene only because a big gubment acknowledgement of breakthrough technology will dramatically increase valuation.
      GLTA

      • 1 Reply to wilderguide
      • "FDA Breakthrough Definition - Does EXEL Merit?"
        Cabo would have been an ideal candidate. After working through the dosing issues, EXEL was in a hurry to get Comet 1&2 underway, but wanted a SPA for Comet 2. After 6 months of negotiating, they thought they were close to a deal, but FDA apparently backtracked. SPA negotiating outside of "breakthrough" consists of infrequent letters and even more infrequent meetings. "Breakthrough" would have forced the FDA into "interactive communication" that might have facilitated a SPA deal for Comet 2 with a pain endpoint.

        The breakthrough program is designed to get drugs into phase 3 quickly. Cabo is already an approved drug with 2 ongoing ph 3's and 2 more soon to start, If the program had started 12 months sooner, there is a good chance the Cabo program would have benefited..

 
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