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Re: BioRecruiter post# 2449

Thursday, 03/29/2012 2:36:13 PM

Thursday, March 29, 2012 2:36:13 PM

Post# of 6072
Bio

One thing I got from the conference call is that Talon does not feel that the Hallmarq needs to be revised and dont seem to have any concerns giving the ODAC panels remarks on it. I think the design of the trial being approved by the FDA makes this a small concern in terms of FDA approval. The SPA essentially is a sign-off of the design by the FDA. One thing I picked up on is that Dr. Deitcher mentioned the Hyper CVAD trail being conducted by MD Anderson which addresses the younger population with ALL when he responded to a question regarding the advisory panel's concerned about enrolling patients 60 and older. Dietcher's argument could be that since Talon has another trial in enrollment that covers a wider age spectrum there is no need to modify the Hallmarq study. Lastly, I get the sense that Warburg may be pushing them towards partnership. My reasoning is that Talon in the past has always stated that they would commercialize Marqibo for Relapsed ALL in the US themselves and potentially partner to market the drug overseas. Their thinking was that because the patient population was so small and giving their tight relationships with the Oncology community they would not need to partner up in order to distribute the drug in the country. From the sound of the CC it seems to me that Talon is looking to partner right off the bat. Just my 2 cents.
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