Replies to post #145320 on Biotech Values

[ariadndndough]

Leerink rebuts Adam 1 AMRN

Stock weakness unwarranted


We believe yesterday afternoon’s stock weakness was triggered by a retail seller, who had to sell at the market, which triggered some sell stops for other investors.
We don’t believe it is anything fundamental.

? Thestreet.com and a competitor are spinning a recent “orange book discussion” on 6/22 posted on the FDA website on 6/27 among senior FDA officials, the company, their attorneys, and Kurt Karst negatively … although everyone we have spoken with agrees with us that it is probably positive.
? There isn’t any more information but this should be a very good sign for approval and potentially having a tighter patent thicket on FDA approval, even if all of these patents are granted after FDA approval.
http://www.fda.gov/NewsEvents/MeetingsCo...

Investors are highly focused on whether AMR101 will be granted NCE status, and we continue to believe that AMRN may benefit from a “presumption in favor policy” at the FDA.
… AMR101 is a natural product like heparins and pancreatic enzymes which have been granted NCE status.
… Interestingly, Kurt Karst is a top FDA lawyer who points this out in his blog:
http://www.fdalawblog.net/fda_law_blog_h...

Meanwhile, MEDACorp patent specialists tell us that “Document Verification” on the PAIR website means that the ‘145 patent will receive a notice of allowance very soon, as in another day or two.
:: This is an incremental positive since ‘145 claims are geared towards the TG lowering findings in the MARINE study, which they stripped out of the ‘889 method of use patent in order to get the ‘885 patent issued.
:: Now they should have all of the claims they originally sought, despite the examiner’s difficulty along the way.

Date Transaction Description
07-05-2012 Document Verification
07-05-2012 Email Notification
07-05-2012 Change in Power of Attorney (May Include Associate POA)

Reiterate Outperform and buyers on AMRN weakness

[jessellivermore]

dear pcrutch...

I am unfamiliar with the notion the FDA might inform a candidate of a regulatory decision, the NCE, prior to a decision concerning the acceptence or rejection of the NDA..which normally precedes the NCE decision..Do you know of other situations that this has been the case?..

FYI...patents are like concertia wire..not always pretty, but usually pretty nasty to crawl through..AMRN is going to have at least a dozen of the these...lots of crawling.

Lets say you are right about the O B "discussions"...AMR101 will most cetrtainly qualify for the clinical studies 3year protection from the lawyers clause...Please do not underestimate how difficult it is going to be for some generic to run AMRN down with a 3 year head start..Never mind the the daunting supply and production problem after AMRN has tied up a substantial amount of the low hanging fruit..AMRNs business plan is going to be simple.."Fast nickels beat slow dimes"...With a customer pool as potentially large as it is, AMRN will be able to slash its margins and still draw in huge revenues..the rationale for most generics is that the Brand Name is way over priced. This game plan does not work if the margins are too low...

Please to not be lulled by the nonsense that AMRN will need an army of salesmen with PHDs to sell the stuff...The primaries will get it "right off the bat" , and I predict a lot of them will be taking themselves, off label.

So even leaving off the fact Teva is going to have to run "bioequivalence" studies to get generic approval..I predict they do not even try...There are going to be much easier fish to fry than AMRN...

JMHO...":>) JL