Today's SA article should give a boost to stock price, stating it's undervalued even now, that market cap should be at least 500Mil, partly b/c the terrible CEO JC is gone and if current CEO takes the necessary steps and deals appropriately with FDA, may well get the approval to make this thing at least double (his estimate -- other analysts have estimated as much as 8X).
Seems to be holding around the $2.00 support today in anticipation.
"...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."
A $500MIL market cap vs. the current only at 350 means price is undervalued by at least 25% even NOW. A reasonable estimate IMO.
AI
