|
Amarin Corporation (AMRN) Amarin focuses on the development and commercialization therapeutic products for the treatment for cardiovascular diseases Amarin has recently asked the FDA to reinstate the ANCHOR Special Protocol Assessment (SPA) agreement for its Drug Vascepa, which is an already approved drug for an adjunct to diet for reducing triglyceride levels in patients suffering from severe hypertriglyceridemia -- the approval is otherwise known as "the MARINE indication." The FDA was set to make a decision on whether or not to approve the supplemental new drug application for "the ANCHOR indication" on December 20th of last year, but has chosen first to consider whether to reinstate the SPA designation or not. The ANCHOR indication is for the treatment of patients with high triglycerides (>200 mg/dL and <500 mg/dL) with Mixed dyslipidemia. This is important for the company as an SPA designation basically entails that if a company executes a trial exactly as it promises it will, and the data is presented as asked for by the FDA, the drug would receive regulatory approval. In this case, receiving ANCHOR approval means the potential to make much more money with the drug. The FDA is bound to honor an SPA agreement once the Phase III trial is completed, as long as the company has followed the agreed-upon protocol to the letter, and efficacy and safety is shown in the data, as agreed upon with the FDA. Herein lies the problem with Amarin, and not with the FDA, as many Amarin investors believe. We have continually informed our followers that we were bearish on Amarin because of its poor management. Having the SPA agreement revoked shows us that Amarin did not follow the agreement as guided by the FDA, and/or simply did not know how to properly communicate with the organization; not some "conspiracy" enacted upon by the FDA to cheat Amarin on the behalf of "big pharma" to stop the drug from receiving the ANCHOR approval. It's also hopeful news for Amarin investors that Joseph S. Zakrzewski has stepped down as company CEO, who has been the main reason for Amarin's failures in our strong opinion -- simply stated, we feel Zakrzewski was a poor CEO. If Amarin's new CEO John F. Thero conveys the SPA case correctly to the FDA, it's a good chance the agreement will be reinstated, which would lead to eventual approval for the ANCHOR indication. If this turns out to be the case, Amarin should at least double in price from its current valuation. We feel Amarin is undervalued here, and should be currently valued closer to a $500M market cap, simply on the fact that Zakrzewski is no longer the captain of what has been a sinking ship. The FDA is expected to make a decision on the reinstatement no later than January 15th of this year. Quelle: Siehe Posting Nr.2 |
|
| aus der Diskussion: | Amarin - The Science Of Lipid Therapy |
| Autor (Datum des Eintrages): | URANI (03.01.14 20:44:30) |
| Beitrag: | 3 von 1,840 (ID:46153445) |
| Alle Angaben ohne Gewähr © wallstreetONLINE | |