to quote an astute poster Avii77 from IV message board
Thoughts on yesterdays news and top line data release
From the Nov CC
Michael H. Tardugno - President, Chief Executive Officer & Director
I don’t think at this point we’re in a position to really talk anymore about interactions with other companies. Although, they are happening and they are frequent and they certainly take some of our precious time and resource, but a priority for the company nonetheless. Our expectation is that post positive data will be entertaining multiple term sheets. Now, whether those terms sheets will address a regional license or larger, will really be the function of other company’s interest. Our sense is on positive data the company will realize the best terms for license. So we’re operating with some patience and expect that our patience will pay off.
And Sia's interpretation:
Licensing interest remains very high, but management basically reconfirmed that they won't sign any license deals until data is released in January, at which point, the company would be "entertaining multiple term sheets". Its been a while since management has promised a large second deal, but they "expect our [their] patience to pay off" when it's all said and done. I personally think a licensing deal will RAPIDLY follow announcement of top-line results with a major big pharma company seeking aggressive expansion in emerging markets.
My thoughts: if management thought they should wait for the data to get the “best terms” I would have to say there is a damn good chance they (and their new partner) now know the final data.
Taking it one step further the question is: if “they” know, why no announcement?
One theory of mine: if the trial is successful they would continue to follow the patients and repeat treat as randomized to collect confirmatory OS efficacy data. However, if the trial is wildly successful, there would be an ethical need to consult with the FDA to allow placebo cross-over. This is what happened with Nexavar in RCC where the p value on PFS was <0.000001. They met with the FDA a few days after the final analysis of the PFS endpoint and the FDA said ethics demand that they give the control group the opportunity to cross (recognizing that the confirmatory OS data would be diluted). Now wouldn’t that be nice? (BTW, if PFS is doubled in this trial, the p value would be in the neighborhood of the Nexavar results above.)
One other unrelated point: I wouldn’t be surprised if there is no winner to Dcups Yahoo contest. ASCO (and other conferences) strongly discourage the release of anything but qualitative data before scientific release. Management said (Nov CC):
Again, as you know, what we’re trying to do is protect the data in order for it to first undergo a peer review process and that will afford us to get publications in very high quality journals. Again, as you know, journals will not publish data if it’s already been publically released.
So for me I’ll be very jealous of releasing much data after that before it goes to a regulatory review and before it goes to a peer review. Again, if you look at other examples of great drugs that work in the area of liver cancers and other cancers you’ll see that that is usually the path that is followed.
So “top line” data may be something like: “we achieved stat sig on our primary endpoint” or “we more than double PFS in this population”. But quantitative data like HR, MST's, P-values? I think we may have to wait to get the exact numbers. (My entry into Dcups yahoo contest for the announcement of median PFS numbers would have had a date of June 1 2013)
AI
