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Oncothyreon Inc Message Board

  • daweasl652 daweasl652 May 17, 2013 2:58 PM Flag

    wedbush

    .......we believe that Merck KgA may be successful in negotiating a path to approval for L-BLP25 ........

    One can only hope they have inside info ; )
    _____________________________________________

    In the report, Wedbush noted, "Merck KGaA(Merck Serono) reported new analysis of the Phase III data from the completed L-BLP25 (STIMUVAX) non-small cell lung cancer trial showing a strong treatment effect in the pre specified subgroup (n=806) of patients who received concurrent chemotherapy and radiation with median OS improving to 30.8 months from 20.6 months (HR 0.78; 95% CI 0.64-0.95, p=0.016). Based upon these results in a pre specified sub-group that represents today's standard of care, we believe that Merck KgA may be successful in negotiating a path to approval for L-BLP25 with the existing and anticipated new data from ongoing clinical trials. Merck expects to provide an update on their discussion with regulators in 2013."

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    • "Based upon these results in a pre specified sub-group that represents today's standard of care, we believe that Merck KgA may be successful in negotiating a path to approval for L-BLP25 with the existing and anticipated new data from ongoing clinical trials. Merck expects to provide an update on their discussion with regulators in 2013."

      The subject of subgroup approval comes up periodically and ODAC, FDA and EMA have consistently and vigorously nixed any consideration for such an approval. The example everyone here should be familiar with is the Stimuvax phase 2 subgroup which had a 17 month survival advantage. That subgroup became the basis for the phase 3 indication which failed to recapitulate that result. Speaking of subgroups in general terms, the results are unreliable. If one looks at enough different subgroups one can find a seemingly significant result. It might be the men of Lithuanian descent between the ages of 38 and 55, you get the idea. Now, speaking of the BLP25 result in specific terms there may be options other than starting from scratch. The subgroup result is very persuasive and significant. There are already other ongoing BLP25 NSCLC trials. FDA may buy into a protocol change that alters the entry requirements to match the subgroup. There is precedent. Dendreon was allowed to rejigger its endpoint computation long after its pivotal trial was underway. Biomira was allowed to expand the Theratope trial to include concommittant hormonal treatment. No guarantee this will work, especially if there have been any interim analyses, but I suspect this is the path Merck is attempting to pursue.

      Meanwhile, competition is not standing still. The PD1 inhibitors and even ONT 10 raise the possibility that BLP 25 might not exclusively own the NSCLC immunotherapy space for very long. One side effect of the result is the resurrected value for ONT 10 and the valuable lesson on what population might best benefit from its potential efficacy.

    • LOL !!!!!!!!!!!!! YOU WISH DOGGIEBOY !!!!!!!!!!! HAHA

      the update in 2013 will pop to 5+ or will drop to $1

      maybe Mrk KgA will flex their muscles overseas, THEIR turf. The European Medicines Association [EMA] might be willing to say " hey fda, we use common sense in Europe, approved."

      In America , when a kid falls down a well, we use 500 men to dig a new well alongside, dig across 100' , bust a hole in the well , bring the kid up using the new well - takes 3 days.

      In Europe, they tie a rope around the ankles of the neighbor , lower him down, pull him and the kid up - takes 1 hour.

    • the next update could be that an NDA is being filed for FDA approval.

 
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