The recent Harvard/MIT study that concluded below came out so recently so probably too late for documents but is the newest study on the subject and goes directly towards what FDA is questioning
The researchers suggests that, even as the exact causal mechanisms are worked out, targeting triglycerides for treatment may be an effective strategy for reducing heart disease risk.
“Clinically speaking, one of the ways to prevent a first heart attack or to reduce the risk of a second heart attack in someone who already has heart disease may be to treat patients with medicines that lower the levels of triglyceride-rich lipoproteins,” Katherisan said. “Some drugs that target triglycerides are already being tested; it is now a matter of finding the right mechanism of lowering triglycerides that will effectively reduce disease risk.”
I emailed the editor and they changed the headline to read:
Amarin Fish Oil Pill May Depend on Heart Study, FDA Says
instead of "Amarin Fish Oil needs Heart Study Result, FDA Says
A little late but at least it is changed. The stock went from 5.75 to 5 after that article came out, I think it helped with the panic selling.
I read the full brief, not as bad as the headlines, still expect positive vote mostly unanimous, devil will be in the answer to how confident they are Vascepa will reduce heart events.
My guess is positive Adcom voted for approval close to unanimous but the level of certainty on it preventing heart issues will not be overwhelming leading to a mixed reaction and the stock needing to wait until December to see which way FDA goes.
They said docs say MAY require outcome study, the headline is misleading and right after was the drop under 5.50. Ridiculous lie to say "Bloomberg confirms heart drug study needed"
From previous CC:
The FDA, through our SPAs, approved our placebo. And over the years, many companies have used olive oil, corn oil, mineral oil, we really think it's much ado about nothing. So we really don't see a difference.
So I see that being questioned and then answered with no issues
Yeah it needs to go to 5.33 or lower or he loses money. The 5.50Put ask is currently 7 cents and he paid 17 so already down 10 cents per Put. If price stays above 5.50 it's 100% loss
He paid an average of 17 cents so needs it at 5.33 to break even. Assuming it was not a hedge and a straight bear play looks like it's going to expire worthless. Volume has dropped each 10 minutes, would take a ton of volume for Put buyer to win
Any self funded programs would continue and I believe drug companies pay money to have drugs reviewed, alot of money and drug companies do not like paying them so I think they would be upset to pay huge fees tog et there drugs reviewed and then told they are not being reviewed. But hard to say if the money collected covers Adcomm's and PDUFA or what/
Congress enacted the Prescription Drug User Fee Act (PDUFA) of 1992. PDUFA provided a mechanism whereby charges were levied on pharmaceutical companies for each new drug application (NDA) filed. The revenues from these “user fees” were used to hire 600 new drug reviewers and support staff. These new medical officers, chemists, pharmacologists, and other experts were tasked with clearing the backlog of NDAs awaiting approval. Consequently, the FDA was able to reduce review times of NDAs to 12 months for standard NDAs and to 6 months for priority applications that involved significant advances over existing treatment. As a result of PDUFA, the timing of U.S. drug approvals began to mirror that of the rest of the world.
n 2014, the user fee will be $2,169,100. If you assume that as many as 50 NDAs are filed in a year, $100 million of FDA funding is by the industry.