I keep looking at the docs, reading boards, long weekend I seem obsessed, it's sad, can't wait until Wednesday is over.
I keep trying to rationalize a reason for a bad Adcomm vote and my mind can't wrap around it, which scares me more than if I could.
Even with A no vote, the FDA could still approve, a yes vote they could still say they want to wait for REDUCE IT but 3 out of 4 times they follow the Adcomm vote so what happens if a no vote from Adcomm?
Company would wait until December and then if denied would need to sell out like Omthera? With Lovaza generic coming and Vascepa unable to distinguish themselves with expanded indication it would be hard to get profitable in Marine only. Getting cash flow for 3 years to Reduce IT? Only with a BO or partner so we are looking at 5-6 bucks a share maximum in a BO, 3-4 dollars as we wait for December. It's been all about Anchor and a denial here is serving a death notice to GIA long term.
On another note related to briefing docs
I notice the VOTE wording is different than the discussion:
VOTE:
Taking into account the described efficacy and safety data for Vascepa, do you believe that its effects on the described lipid/lipoprotein parameters are sufficient to grant approval for co-administration with statin therapy for the treatment of patients with mixed dyslipidemia and CHD or CHD risk equivalent prior to the completion of REDUCE-IT? Please provide the rationale underlying your recommendation.
VS.
Discussion:
Please discuss the efficacy results from the ANCHOR trial, including the clinical significance of the observed changes in lipid/lipoprotein parameters and your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population
Oddly if you take out the phrase "prior to the completion of REDUCE-IT?" in the vote area there is no difference to the question because obviously right now is before completion of REDUCE IT. Clearly they want them to factor this in but voting itself does not ask the panel as detailed a question as it could have been. They are asking should we approve without outcome trial not should we approve because your opinion says it will reduce cardiac events. A panel member could feel 80% REDUCE IT will fail but still vote for approval based on no safety risk and 20% chance still a chance. Clearly the FDA, when deciding on approval in December will not just look at the votes but will key in on the discussion -especially "your level of confidence that these changes will translate into a meaningful reduction in cardiovascular risk among the target population"
Not sure it is meaningful at all the way the vote question is worded but interesting. I think the wording could lead to a situation where the panel votes yes but the discussion, depending on opinions of the panel could lead to an FDA no. Theoretically.
