These guys need to clarify the validity of their patents and process. If they do not, this PPS will just labor around $6. Who would be stupid enough to invest a company who's IP is now at question with respect to its process to make $$$ ?
They need to stand up a set the record straight !!!
Am Academy of Cardios & Am Heart Assoc HAS NOT changed it's opinion on lowering trigs nor has a significant study surfaced that has disputed the relationship of high Trigs and CVD or cardio events. Yes, some studies came out that DID NOT support this conclusion. BUT there results did not directly dispute the high Trigs and CVD problem an any manner. They sort of proved a negative not a positive...that's not a drastic change that is the basis to alter or stop a SPA.
The FDA just told the ACC/AHA that their treatment protocol is all wrong for Trigs and CVD. There has been NO significant study results to reverse the manner in which Cardios treat this problem. The ACC/AHA should fire a volley at the FDA's recent statements. Has the ACC/AHA in their journals altered their position on how they treat this category of patients or cited any significant new studies ?
Does this mean that Cardiologists will no longer consider this category of drug for high trig patients?
The FDA decree infers that Cardiologists should not prescribe EPA/DHA drugs for their patients in this catergory. This really makes no sense.
The FDA should throw ARMN a bone, and approve 300-500 trig levels for this drug WITH NO label reference to reduced CVD's. It works great, its safe, and yet this hatchet job by the FDA may be a death blow.
It just feels strange that without REAL DEFINITIVE new study results, they overturned all the prior work on this treatment approach for at risk heart patients.
NONE of the recent 'evidence' about CVD events related to EPA. So how the hell did the FDA use that excuse to frame the question ? Someone at this FDA oversight panel was either real stupid or very calculating. The question was posed to emit NO vote.
That wasn't the terms of the SPA, nor has any 'demonstrative medical studies' overturned the relationship between high Trigs and CVD. Jelis and the latest study analysis of EPA's are the most definitive 'science' about EPA therapy. Yet this panel, due to the nature of the FDA question(which was not phrased to coincide with the SPA objectives & endpoints) was confused and directed to a different evidentiary focus. Just look at how confused members were and how defensive that 'sponsor did everything that the FDA asked and performed the SPA objectives'.
THIS HAS TO BE CHALLENGED
The patient experience is what has been missing from the entire story of V. Why didn't their marketing dept get patients to tell their story and successes with V. Less inflammation, reduced joint pain and discomfort, 'I now use 1/2 my statin dose and have improved markers'.......and the testimonials go on.
So, where are they ?
It would be nice if Joe Z came forth and actually told the shareholders something significant; like the truth. Oh, I forgot, this is an Irish company and they don't have to tell us nothing.
I'm also in that club. And, I can't analyze this situation and say where we should have seen this coming. I've dumped 70% from a $6 avg, so the pain is real. Still holding based upon $2 being the floor.
So, we get AMRN to send each of us 50 Vascepa brochures that we can deliver to every Cardiologist that we drive by. I made my 1st visit to a Card 3 weeks ago. His response was Vascepa, what is it ? He does routinely script Lovaza.
AMRN has an army of mad and financially hungry shareholders that are willing to lend a hand.
How about it ???
This is nothing more than an evaluative analysis of the prior studies that were conducted. The AdComm panel blatantly refused to acknowledge any of the previous studies as definitive or valid. They stated that there is no work on CV event prevention that shows a clear and demonstrative relationship based upon Trigs; and that the reduction of moderate to high levels can effect CV events. So, how is this article going to help the mess we now find ourselves in ??? It is he said...she said. And, oh by the way where are the authors from?
If the FDA held the panel 'on course' with the AdComm endpoints and objectives, we all would be celebrating. How the hell did ReduceIt become the keystone issue and CV events reduction get tied to the topics under discussion. There has been no new studies that refute Jellis, nor have Cardiologists suddenly started to ignore Trigs levels 200+ because this panel says there is no correlation. They single handedly changed the diagnostic evaluation points used by Cardiologists....I Don't Think So !
Where is the study and who wrote it ? Still haven't seen a journal or author reference that is verifiable.
I think they were all so caught by surprise that they did not have comments for that panel result. This was supposed to be a celebration CC not defeat. They said everything is on the table, which is wordsmithing for 'What the Hell just happened ?
Then how is it that EVERY Cardiologist will panic if you present with Tri's above 300 ? Because they are trained and current science says that you are at greater risk for CV event and other organ related issues.
And if there is other indications; like diabetes, they want the Tri's down NOW!
So, how is it that this AdComm panel just claimed to have changed the diagnostic parameters for almost every cardio patient ? Because they say that high Tri's is not important for Cardio health and events.
No new definitive study has surfaced that disputes the standard of care and Tri levels as they relate to patient treatment practice for the Cardio Dr.
Let's see: 1 product company & Irish based corporation & obvious negative market bias (has been forever)
& no NCE & FDA panel massacre & tremendous debt & no chance of raising any capital at this
You think that is a little negative ?
For those acquiring at this level, they don't have much downside risk. Why not buy?
They have had since 10/16 (and I hoped they worked the weekend) to determine what their options look like.
So, when are they going to make a statement ?
Their silence will kill the PPS and lead to the eventual final explosion. Even if a partner came in now, with their debt and lack of FDA decisions (Anchor & NCE) it ain't worth much.