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Oncothyreon Inc Message Board

  • arhdan9 arhdan9 Nov 15, 2013 5:49 PM Flag

    Ont-10 Makes Tumor Shrinkage __ Approval Within One Year According to FDA Accelerated Approval

    According to FDA on "Accelerated Approval," Ont-10 has the chance of being approved within one year!

    "In 2012, Congress passed the Food and Drug Administration Safety Innovations Act (FDASIA). Section 901 of FDASIA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow the FDA to base accelerated approval for drugs for serious conditions that fill an unmet medical need on whether the drug has an effect on a surrogate or an intermediate clinical endpoint.

    A surrogate endpoint used for accelerated approval is a marker - a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. Likewise, an intermediate clinical endpoint is a measure of a therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug, such as an effect on irreversible morbidity and mortality (IMM).

    The FDA bases its decision on whether to accept the proposed surrogate or intermediate clinical endpoint on the scientific support for that endpoint. Studies that demonstrate a drug’s effect on a surrogate or intermediate clinical endpoint must be “adequate and well controlled” as required by the FD&C Act.

    Using surrogate or intermediate clinical endpoints can save valuable time in the drug approval process. For example, instead of having to wait to learn if a drug actually extends survival for cancer patients, the FDA may approve a drug based on evidence that the drug shrinks tumors, because tumor shrinkage is considered reasonably likely to predict a real clinical benefit. In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually predicts that patients will live longer. These studies are known as phase 4 confirmatory trials."

    to be continued

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    • sine P1 and P1b is ongoing, there is a chance that they will continue to get responses that yield further tumor reductions. But they would need more of that to be considered in the way you are suggesting. As they enroll more patients and fine tune the procedures maybe they will see more. But until then, your scenario will take time to see if it can play out that way. yes a lady with ovarian cancer saw tumor reductions but they would need to see more people respond imo.

      • 1 Reply to jyardagg
      • If they narrow their targets they can get higher response, of course the drug would be less valuable. But they need to clearly describe and spell out what they drug intends to treat and make sure they have a good enough response rate in that population. Too me it just seems the market is not giving much value to the potential for this drug getting FDA approval. I saw a reversal story with anika earlier this year I banked huge on that one. The stock got hammed to 100m market cap, then one day they state things should probably get approved and it triples. Think something similar will happen here, as anika also had very attractive book value and lots of cash.

    • Oncothyreon should conduct a Phase II study of Ont-10 to seek accelerated approval for Ont-10 for ovarian cancer ASAP while pushing Merck KGaA and other big pharms to either offer buyouts or partnerships.

      Kirkman should just do that, if he is not too old to be active!

      • 1 Reply to arhdan9
      • The FDA calls such approval " the breakthrough therapy designation pathway", a designation earned if preliminary clinical evidence indicates the drug may offer a substantial improvement over available therapies for patients with serious or life-threatening diseases.

        Kirkman should go for that, not waiting any minutes!

    • Where confirmatory trials verify clinical benefit, FDA will generally terminate the requirement. Approval of a drug may be withdrawn or the labeled indication of the drug changed if trials fail to verify clinical benefit or do not demonstrate sufficient clinical benefit to justify the risks associated with the drug (e.g., show a significantly smaller magnitude or duration of benefit than was anticipated based on the observed effect on the surrogate).

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