With no movement in share price, this seems like another pre-arranged trade; like last week.
Somebody "sucking up" shares and working to keep the price down in order to "pass off" an order to an institutional investor.
Watch the change in ownership data when it becomes available in October to gain some insight as to who might be involved.
With these numbers, keep in mind that much of the sales force may have been sidelined with training during the week as a result of the first amendment decision. Amarin would have had clearer direction regarding things such as what they could or could not say, and new paper/hard copy and digital materials (as posted earlier) etc. The sales force coverage or effectiveness could have been as low as 80% if each rep required a full day for this new training. On this basis a "normalized" TRX figure of more like 14,000 or more is not unrealistic. It will be interesting to see the figures in a week or two.
From. PACER, it is the deadline imposed by the judge. For Amarin and the FDA to present a compromise in the hope of averting a trial or further actions. Some think that the FDA will need/want to make concessions to "contain" this issue.
FYI an appeal was filed last night just before the end of the 30 day period.
Pretty much the same claims that management are a bunch of "cheats and liars".
Jury trial requested.
Don't know how long this is going to drag out/be an overhand or what will result.
So much for a clean break of things going into August.
After having finished a quick read of the submission, I sincerely hope that there might be a way for the judge to find the FDA legal team in "contempt of court", or the likes, for "wasting time".
Can't get my head around whether this is "news" or baked in from a few weeks ago (with "Watson" causing the recent price drop) but 43 million shares at $1.50 sure seems as though it will have a dampening impact on any good news on Monday.
Will we ever get to $2.86 (when another ~ 52 million shares potentially kick in)? Are we completely dependent on REDUCE-IT and buy-out to get out of the doldrums?
Hi XXX, I'm not entirely sure why the motion wasn't brought in the name of Actavis/Allergan, but the motion certainly seems to be genuine. I'd note that Watson has also been named in recent IP litigation that Amarin filed separately, so I imagine there's just some technical reason (perhaps the generic version of Vascepa was originally developed when Watson's name was still in use, but I really don't know for sure).
I've reached out to Actavis/Allergan for clarification and will let you know if I hear back. Best ... Jeff
Back to Him
I’m intimately familiar with the overall situation, which is complex.
Monday (July 27) would be the last day of the 60 day appeal period for Judge Moss’ decision of May 28 to effectively force the FDA to grant New Chemical Entity Status (NCE) for Amarin’s drug, Vascepa. The saga leading up to the original suit of Amarin vs FDA is fascinating with blatant arbitrary actions by the FDA, long delays and retroactive and selective application of draft, unapproved guidelines to prevent Amarin from receiving NCE.
The original period of exclusivity for Vascepa as a result of its (until the Moss’ decision) New Molecular Entity (NME) status also expires on Monday. There are at least six other generic manufacturers who are hovering like vultures to begin manufacturing and marketing. If NCE holds, they are shut out of the market for a few more years.
The real prize, possibly seven to eight months away, will be able to piggyback off of Amarin’s REDUCE-IT cardiovascular outcomes study interim results to potentially claim that their products reduce cardiovascular risk. Amarin is beset with all of the costs but a quirk of the generic approval process is that the generic manufacturers may easily be able to make the claims.
Vascepa, which has no nasty side-effects, also has the potential to reduce reliance on statins, so the monetary consequences are truly in the billions of dollars.
No response from Overley but it is real. The "real meat" of the submission is sealed, so nothing to share.
Very interesting that Wiey Rein (Floyd Abrams' firm) is assisting Watson!
I concur with your overall assessment. There are many positives and an underserviced market.
I'd say that there is chance that JNP becomes an attractive takeover target, and that with good trial results, the share price could be higher than $15. Keep in mind that $15 is really only ~ $1.90 before the reverse split.
It seems typical of past drops when somebody has been trying to accumulate exploiting the associated fear and anxiety.... big bid volume at low price..
Anyhow, I haven't been able to follow this as closely as I would have liked. Just what is the "FDA argument"? Are transcripts of the session available yet?
You don't think that the FDA will appeal the NCE decision just out of spite? If they were to, while it would definitely send a signal as to their bias, it would open the "barn door" to "accept" the ANDAs. Once they're "out", we're into "terra incognito". I know that there has been an agreement to "stay" the suits on NCE; however, part of me fears that we could still be three months away from a "fuller and meaningful justice". That there has been no significant rise in the share price suggests that the market might not think that this is over?