Because AMRN ran their trials under a SPA and have met all the requirements of the FDA the ADCOM could be used as a way to grant Vascepa early approval... Yes the one point that is correct is that it also can be done bc Vascepa is first in class to treat that anchor mkt, but the facts are bc the trail ran under SPA and all req have already been met the FDA could be looking to see if the advisory committee feels the same way so approval can be granted early..... It is very very rare that the FDA goes against the adcom when they already are positive on a drug...
So the truth is that in AMRN's case if and that's if they do have the adcom meeting it is more a chance that its a positive and if the committee comes back as positive as the FDA the stock will fly.....
These shorts and AF need to start telling the whole story. Such losers... And AMRN is simply preparing for it bc that's what they should do.... The games are becoming more and more pathetic w AF and company.
Right on target harvey but won't help the lemmings. Your post will get buried in 100 bullrider wchuck41 bs posts. #1 Thero said preparing for ADCOM not that it has been decided and #2 I will be praying for ADCOM as can only lead to positive conclusions and possible early approval. AF paints this as some horrible hurdle implying our drug is needs special review as a problem has been found. Truly criminal! Maybe if folks knew what a SPA was and how we blew those requirements out of the park this would make more sense.
Not all, but yes they are common. It's not a reason to be concerned unless there is a fatal flaw in the efficacy or safety data that could create a hailstorm of discontent. Even with some big names coming out against approval without outcomes data, the overall adcom should IMO approve since there is very minimal risk to moving ahead with treatment now versus waiting on the outcomes data and there may be (I'd say probably is) significant benefit. The rub is a general school of thought that FDA should wait on outcomes data before approval, but they already considered this when they granted the SPA, so those opposed will probably end up on the minority side of this one. There point is well taken, but better to treat than not to treat when it comes to patients ahead of the data when the treatment has little or no downside health risk in the patient population.
Sentiment: Strong Buy
I listened to the Jefferies call and thought that Mr. Thero indicated that Vascepa therapy had early data that showed LDL was lowered 51% when combined with statin therapy and 29% without statin therapy. I believe that is a good indicator of the safety and effectiveness that is enhanced with Vascepa treatment. The Marine indication for patients with high triglycerides has been picking up increasingly more prescriptions as the education of ~30,000 physicians continues. He did touch on a topic that was reiterated twice in his presentation and that was that Amarin has no plans to hire additional sales staff when the Anchor indication is approved. This I felt was pointing to either a buyout or a partnering agreement within the next six months or prior to December 20th. I am having a problem understanding what The Street article was pointing at? There was nothing in the presentation that would indicate any problematic upcoming events. In fact Mr Thero mentioned the FDA a couple of times but Not in any adversarial way but rather in a step-wise method to bringing a needed medication to fill an unmet medical need. I thought that the presentation was both thorough and informative; although no new information was presented. This was not the target of the Jefferies conference but rather more of and update.