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I wish the Baker Brothers cared enough to find a CEO who would.
What does it take to turn the board against this stammering moron.
It won't happen with captain p*ssy McStammer as CEO.
He doesn't even have the guts to use his 1st amendment win to advertise DTC.
Can you screenshot the tweet as "this account's tweets are protected".
Thero needs to go.
"At least our CEO hasn't fled the country"
Too bad...
Why the guy sold so many calls...
No doubt that if the patent situation were resolved and sales started going well and the stock were going up and people even started ignoring the almost daily hitpieces the biotech CEO of the year would just issue some kind of terrible updated guidance of increased expenditure in order to tank the stock again.
The biotech CEO of the year strikes again...
JT could put a meth addict to sleep when he talks, and if he were teaching high school sex ed the teenage boys in the class would come to quickly conclude it was boring and not worth doing.
In Wall Street Gordon Gekko said "If this guy owned a funeral parlor no one would die" but if JT was CEO of a publically traded funeral parlor company he would project that nobody would die...
re. the Hayashi study – that the examiner accepted as true Dr. Lavin’s opinion that the prior art did not teach administering purified EPA to patients with triglycerides of at least 500 mg/dL, which the parties now agree was incorrect
"JT has no control over the stock price"
I agree with you, lets get a CEO who does.
We could achieve script growth faster if we had a bold CEO who would use his victory in the 1st amendment case and began IMMEDIATELY advertising the label DTC.
JT wants to wait another six months for the FDA advertising office when legally we don't need to anymore.
1. If the stock tanked immediately then at worst nothing would change and maybe we'd get a bottom at least...
2. You would think firing the CEO would at least in the short term be bearish, but you would think a drug approval would be bullish so who knows.
"but he says it with authority and people believe it..."
That is what he understands and Thero does not...
Goldman Sachs also thinks Thero ripped them off with that dilution (they definitely think he knew about the adcom). Maybe they are backing the shorts here... maybe they are a lot happier if he goes away.
That is what I was asking...
Link to contact board members (particulary the Baker Brothers representative) we should all express a wish that Thero be dismissed as CEO.
1. They need PIs for that analyst and his managers at Oppenheimer as well as Pyrr until they find out who these astroturfers are...
2. I think Thero needs to go, his extreme conservatism and utter incompetence as far as public speaking keep screwing us over. Even given that he had good timing he did not need to raise 400 million dollars (his good timing made me think he expected a royal screwover with the FDA)... he needs to provide optimistic guidance from this point on and talk up the stock. Now that he has the label direct to consumer marketing should be launched immediately using the coverage we have under our 1st amendment win, no waiting months for some other FDA approval. He needs to tell the insurers that any obstructionism with regards to "cardio-candy" coverage will result in a Martin Shrkeli sized price increase in the population they do have to cover (patients with good plans without big deductibles won't care). The new management should also let it be known that they expect company officers to dedicate a certain % of their salary to buying stock on the open market from this point on at regular intervals for the forseeable future.
I'm confident in the drug but I'm tired of this shit the company needs to get a lot more aggressive and nastier about the way they need to do things. No one gives it to you you have to take it.
His masters are though (and yeah I'm sure there are probably a couple of intermediaries between them and Pyrr) and following him is a good way to find them.
AMRN needs to spend a bit of their money to hire some private investigators ones who aren't afraid to bend the statuatory limits of what their allowed to do to get at the truth, everything Pyrronian does should be watched.
Pyrr is just a pawn of greater forces but if observed long enough should be able to unmask who the conspirators are...
Re: Next year
It sounds like you are bearish if the company goes it alone... why exactly?
Sales should be way up, generics even if they do come in will be 10 years away.
FDA Briefing Docs for the Adcom...
Does anyone know if the briefing documents supposed to come out a month before the meeting or can they come out at a later date, like say a week or even three days before the meeting?
Hopefully we'll get news within the week that McCabe is being indicted (hopefully they can do it outside of DC somehow. bureaucrats need to be tried in the styx not the capital) that will be the beginning of the end for the two tiered "justice" system in this country.
And then in the future the FDA bureaucrats will realize they have to worry about indictment... China did the right thing when they executed the head of their FDA for corruption, it would be nice if it happened here.
I'm not playing tough either... my long position is smaller then it was I have a lot of cash I intend to buy in 10-12 but in the end they'll get the label.
If the worst happens and the FDA screws them over completely with a CRL... Trump will have the excuse he needs to rip the FDA apart completely the way hes (RIGHTLY) always wanted to.
The insider info the shorts have this time is merely that the FDA intends to drag this out for as long as possible. I agree with JL and others that the FDA probably can only delay the label not deny it.
If you don't see that keeping drugs off the market for years while the FDA makes them jump through billions of dollars in bureaucratic hoops drives up the cost of medicine... I don't have the patience to explain it to you.
If something didn't exist before the progessive era then its almost certainly unconstitutional, but to elaborate the idea that the government can keep products off the market in the name of protecting people from themselves and "evil" businessmen is unconstitutional (9th and 10th amendment, also outside the government's ennumerated powers and relies on the New Deal's mutilated reinterpratation of the commerce clause), socialistic and pozzed.
As for corruption bureaucracies naturally try to grow their power, budget and juristiction (per Jerry Pournelle's Iron Law of bureaucracy), but most bureaucracies people can sort of evaluate what they are doing and how well so they are subject to some degree of outside scrutiny. The FDA given that it is a supposedly scientific bureaucracy evaluating obscure points of data is naturally far more opaque then other bureaucracies and also there is a lot of money at stake. Fertile ground for corruption.
If the FDA was honest and good... would not be hard on a drug with no real side effects and huge proven benefits. It would not have delayed its PDUFA it would in fact rubber stamped the biggest label possible as soon as the application was in place.
My remark on big pharma was a side note. Delays for big pharma are not nearly as injurious as delays to single product biotechs.
What is your interest in defending the most corrupt agency in the government? One that both from the point of view of controlling the cost of medicine and from the point of view of the constitution should not exist.
The FDA is playing the delay game...
Since the FDA (and AMRN's enemies outside of the FDA in big pharma) do not have a good enough excuse to throw out Reduce-It they will try to delay everything for as long as possible.
November 14th is unlikely to be the date... don't expect an Ad-Com until mid December or even January.
As I mentioned in the previous post, Yes they can.
Not being the company I would not have standing.
So you do not know whether this they can call an adcom anytime they want even if it delays things... is part of the statute?
Was this part of the statute that created priority review or some reg the FDA made up themselves?
Regardless of technicalities it is still arbitrary, capricious and despicable and I don't understand why anyone here would want to defend the Fatal Delay Administration.
An AdCom is well within the responsibilities of the FDA and is therefore the exact opposite of arbitrary and capricious.
Are we supposed to love Mary Parks and the other corrupt bottom feeders at the FDA?
Biobill...
Of course they are delaying the PDUFA date... the FDA are obviously out to screw us as much as they can get away with. If they just gave us a standard review with an adcom it would have been better then this headfake they did.
Its okay I had to sell a bunch of shares (I had a modest margin position) so I want the stock to go down in the short term as about 1/3 of my position is now cash. I'd like to see it go down to 12-11 some time before the adcom. I really really don't want them to annouce it was fake.
Should go down into the adcom... I mean Mary Parks (good find on your part I thought she was gone but the b*tch just changed her name) I'm not gonna say we've seen this movie before but it does look kinda like a remake.
The reason for the talk of CRL is because nobody trusts the FDA after this adcom decision, they've proven again and again that they have a level of corruption and incompetence you'd expect from maybe the Mexican or Nigerian government but you wouldn't quite expect here.
JT should not have announced it immediately IMHO...
The announcement should have coincided with a lawsuit being filed against the FDA for "arbritrary and capricious" demanding an emergency supression of the adcom and that the court order them to keep the PDUFA date. Furthermore that all things significant in the Reduce-It study would be on the label at the bare minimum.
The FDA obviously needs new laws constraining its behaviour.
1. All its sovereign immunity needs to go away, every FDA action should be challengable in court. Its too opaque, incompetent and corrupt to deserve any "deference". At the very least broken SPA agreement should be immediately challengable in court without going through FDA appeals. Yes this would render the FDA mostly a paper tiger but that is exactly the point.
2. It has too much incentive to deny drugs and not enough to approve them. FDA employees need to become civilly and criminally liable for not approving drugs or even delaying them if they later turn out to have acted wrongly.
What caused the adcom is relevant to some other things besides the credibility of MRC (we all know Pyrr is a bs artist who probably got lucky)...
If the FDA did it because they are stupid or are in cover their ass mode because they got a letter from the 5 commie senators, I still hate the FDA but they are less likely to try to cause problems in the future.
If on the other hand the FDA did it because they have a vendetta against AMRN because we sued them and won twice, or are acting the way they are because corrupt officials are taking bribes from big pharma, or with an understanding that they will get jobs from big pharma... the FDA is likely to try to cause more trouble in the future.
Because while I would like to believe the Democrats will never be in power again (because we will resemble Venezuala in short order) they probably will be someday... bureaucrats have to take Senators seriously, and even in the minority the Democrats can influence the budget.
The FDA bureaucrats would certainly care more about what 5 senators say then a bathroom installer, a disgraced ex doctor and a doctor who is a paid shill for Astrazeneca (they care somewhat about the Astrazeneca job because some of them hope to get a sinecure VP job with Astrazeneca).
MRC had nothing to do with getting the adcom setup.
Lizzie Warren and her merry fellow communist Senators who told the FDA (post Novartis data debacle) that they need to be extra annoying did.
Good post as to the why of it your explanation here makes as much sense as anything...
So because a dirty big pharma commited fraud and a bunch of dirty commie senators made an issue of it we are victimized at the hands of dirty corrupt bureaucrats. Makes sense...
https://www.fiercepharma.com/pharma/sanders-warren-join-team-senators-blasting-novartis-zolgensma-data-rig
Pyrr should be lucky that not everyone thinks the cause is him, if he did this himself and everyone thought that... somebody would do something given that hes cost a lot of people a lot of money... I personally don't think its him. I don't think the FDA would care what he says though... I think his citizen petition was merely a pretext for what certain FDA people are doing as a favor to big Pharma (Astrazeneca most likely).
He doesn't have theories he works for someone... most likely (with some intermediaries in between) Astrazeneca.