Its interesting that the FDA did not delay the ADCOM before the storm given that they had the SRPT new data 2 weeks before the adcom. Only after the storm did they conclude that the new information was material. I think this has to bode well for a revised briefing docs.
Requires 15 days from when posted in Federal Register. Likely 3-4 weeks out because publishing in the FR can take some time and they will need to get dates that work for everyone's schedules.
The FDA rules require 15 days notice after publishing in the Federal Register. There are some narrow emergency exceptions. Will be interesting to see how long it takes even to post in the FR and then provide the 15 days. Looks like mid-February for ADCom unless FDA feels the urgency to post quickly in the FR..
I am long in this sock but suggesting that the FDA delayed the ADCOM because they made is mistake is absurd. Washington shuts down with an inch of snow and the forecast is for a lot more. The bad news is that there will likely be a substantial delay because the new meeting date must be noticed in the Federal Register, which could add several weeks to the process.
I find that the Bayer site provides interesting information that may speak to just where CGEN stands in the immuno-oncology development field. A December 23 article on the Bayer Yahoo site notes: Key points on Bayer performance
Bayer announced that it’s accelerating its investments in more cancer drugs.
Bayer is on the way to achieve a bigger share of $100 billion global markets for cancer treatment.
Bayer said that it may have five cancer drugs on the market by 2020.
David Weinreich, who oversees development of Bayer’s cancer drugs, said, “We want to be a major oncology player.”
I would think the next few deals announced by Bayer will speak to where CGEN stands. Given our current relationship, it seems reasonable to think that CGEN would be in one of those deals if we really have positioned our science in the right areas. Who knows us better than Bayer? Follow-up deals with Bayer would show we are on the right track and ahead of the curve. The lack of follow-up deals with Bayer would make me begin to wonder if something is amiss. Does my reasoning make sense to other long term investors?
You are naive if you think the stock price would be driven by how CGEN conducts its PR. Funds and large players will not make decisions based on a PR release but by more thorough analysis and discussions with management. This stock will move once more deals and scientific advances are announced and that is not PR but proof that the Company is meeting business objectives and bringing products to market. The shot term PR is meaningless for long term investors..
As for the second molecule,I suspect they are close to the first milestone which if like the other molecule would be $1.2 million. It was july. 2014 when the first milestone was paid on the other molecule and a second $6 million milestone in October 2014. I would think that there would be lessons learned on the first molecule that should help move the second along.
I think today's news is extremely important. It signals that CGEN was able to use its computational methodology and successfully take a molecule to pre-clinical stage with a world class partner. It should add value to the other pipeline candidates and should also provide some good lessons learned from this collaboration. I would also expect to hear about a $7 million milestone on the other molecule given the promising language in today's press release. I also suspect that Bayer will take an interest in other molecules particularly if the article today about Bayer is correct. One distant thought is why would Bayer continue to pay milestones and potential royalties given the track record of CGEN when they can own the whole company for not much more.
Not sure who the analyst was last week who gave high percentage likelihood that BDRM would get approval and somewhat lower chance for SRPT. Just shows how little they really know and maybe their motives drive their "analyses" rather than being fact based. The good news is that the FDA really did their homework as did the ADCOM. Hopefully given the significant differences in proven efficacy and safety profiles, we will see the science winning out particularly given the risk benefit analysis since the efficacy and safety both are positive. It was good that SRPT is going second because the contrast is clear and the unmet need is highlighted even more clearly given today's patient testimonials and the acknowledged frustration noted by some members of the advisory panel that there is nothing currently approved to help these patients.