Most know about the expiration date that is not the issue, but how do you know there is no claimant? I mean there are many firms who jumped in? I have not seen it anywhere till spader mentioned it. And its funny if there was no claimant and the cases was terminated how come no one mentioned it till this post?
izzyallthere, sloanschoolgrad, myuncIejuney , stanley_rnyron_kederski, tagetlocman , portsrnouthohio (on double secret probation) , rii_666, elmaestro111, kathycronkite ,crecy_wart_knight, cathycronkite, mercury7astro, harvardphd1972, donnatello465, harvardmba1972, zoom69zoom, bobkidder89, sparrowjack6543, ri66, astroandaeromit, myunclejuny, acad_moronic_poster_hunter, lashundadaniello1154,
tradingexpert4ne, harvardprof1988, dilk_is_pathetic_broke_dumb, sc00by_d0o, samandjoeshow, harvardmba1973, scalpelxpert45, naum_98. More to come as the sp rises.
Now this last part about the BB selling...I have no clue how they came to this conclusion and I don't agree with it. I would doubt the BB/Fidelity would sell this close to approval. Imagine how they would feel if approved and they were out? They would lose...multi-millions.
Estimating the number of persons effected by psychosis (= delusions + hallucinations) is difficult due to the perceived stigma patients could face so they prefer not to divulge.
Conservative peak risk-adjusted 2027 pimavanserin PDP revenue estimate by LEERINK (based on 45% share of PD antipsychotic use) is of $1.3B (US excl ROW)
à Specialists with whom Leerink spoke are optimistic on pimavanserin’s prospects in ADP and more importantly, most plan to use the drug off-label in AD and psychotic dementia once it is approved in PDP, largely due to its relatively cleaner safety profile
Patent expiry is expected in 2028 so ACAD has 12+ blockbuster patent life.
Schizophrenia (approval potentially in 2020) and ROW sales are all upside
Given the scarcity value of a novel CNS drug that is safe and effective, ACAD could be a likely takeout target. CNS companies are full of “me too” depression drugs with generic competition – there is no sector of Big Pharma more in need of acquiring a blockbuster differentiated safe and effective blockbuster with long patent life.
Recent stumble with NDA delay and CEO departure may make institutions like Baker Brothers and Fidelity more likely to sell even before approval.
Just a copy & paste from one of the IV stock MB's. FWIW-Acadia Pharmaceuticals (ACAD)
ACAD is an entity with a 100M float of which 46% is owned by 4 major holders: Baker Bros (20.5M); FMR LLC (15M); Price T Rowe (6.2M) & Vanguard (4.9M). Another 50% is owned by institutions.
ACAD ‘s pipeline is all about PIMAVANSERIN which has a different pharmacological approach to treating psychosis and is being tested for: Parkinson’s disease psychosis (PDP) under name NUPLAZID; Alzheimer disease psychosis (ADP); and Schizophrenia
Pimavanserin was awarded Breakthrough Therapy Designation (BTD) by the FDA after it generated positive Phase III data which showed a reduction in psychosis symptoms and an exceptionally clean safety profile
NUPLAZID was to be submitted for an NDA in Q1 15 however the NDA was be delayed and the CEO retired.
This is the second time the NDA got delayed.
The reasons for the last delay were due to manageable issues related to preparation for the FDA’s CMC review (not actual drug production but “quality assurance” protocols)
Stephen Davis was added as interim CEO who has extensive experience in multiple biotech companies; and the board was expanded.
Davis also made important operational changes, and is working with consultants on establishing quality-assurance protocols ahead of an NDA review.
NDA submission is expected to be made in late 2H 15 with approval in mid 2016
At a recent symposium at the American Academy of Neurology (AAN) meeting on the dynamics of (PDP) and current treatment strategies, the significant unmet medical need presented by Parkinson's psychosis was highlighted
In the aggregate, panelists/audience members at AAN estimate that ~50% of their Parkinson's patients are afflicted by psychosis
On the other hand, according to the Parkinson's Disease Foundation, PDP develops in up to 60% of the estimated one million patients with Parkinson’s disease in the U.S., commonly causing visual hallucinations and paranoid delusions.
Name calling,,,,naughty boy. Did I call you names? No, You want to buy ITCI, be my guest. BTW, I have worked in the medical profession over 30 yrs. When it comes to brand name drugs its all about the cost-the bottom line. When new drugs come out the average doctor can not prescribe them with out approval. No health insurance will allow that and will not pay for it. So say the doctor (FM, Int Med, ER doc, Neuro & Psych) does write for a new drug and the patient shows up to the pharmacy. The tech at the window will look up the patients benefit and that's where reality sets in. He has to pay FULL PRICE. Ouch! Most patients will refuse. Then they figure it out...get a generic. So if some side effect occurs, in this space there are many other choices. Don't try to tell me I am narrow minded I have the experience to back me up.And probably have done more DD on ITCI than you.
And btw ITCI is constantly telling how their drug could be used in PD, but have no ongoing study , not even pending. They are about 5-10 yrs away from any kind of PDP pivotal study. Or perhaps you know something no one else knows? So show me the ITCI PDP study - you can't. Now did I call you any names? So who is narrow minded, someone who does DD or someone who just doesn't like what my opinion is?
l don't see ACAD being much competition to ITCI at this point. You understand there are several other biotechs doing R&D in Schizo. Acadia is mostly a PDP(Parkinson Disease Psychosis ) play, and ITCI will never be in that space with not even a preclinical PDP study at this point. But boy do they love to boast about it. As far as PDP being in a smaller space than Schizo, yes. But how many patients can ITI-007 get? Here is there real competition : Clozapine AbilifyTM GeodonTM LatudaTM RisperdalTM SeroquelTM ZyprexaTM, not Acadia. Keep in mind the other companies will not give up space easily. And insurance companies with their Protocols will slow the sales of most new drugs that enter that space. Even though some patients will stop drugs due to side effects the insurance protocols will not pay for a new brand name drug (pricing is everything here) until other less costly drugs are tried and failed. ITCl will make some money if approved, but will not take a significant % of the market for 3-5 yrs. The situation is way different with ACAD, many of the competing treatments listed might help the psychosis but make Parkinson's Disease worse. Their is where ACAD will make its money and fast. It will be the only drug indicated for PDP in a space with few options. Insurance protocol will have some effect, but not as much as in the Schizo space.
I will dedicate my poem to your dad:
I venture into the land of my fathers
Into the canyons cut a mile deep
Where rivers flow
Like great silver snakes
My country, my home
On the great mountain tops
Where the eagles are king
Prayers echo into the night
Where the plains silently sleep
Distant valleys are calling me onward
To keep moving to greater feats of God
Great oceans, lakes and shores have no peers
The deadly blistering sands are alive
Hiding their life
Like a statue in the night
It can call forth scorpion armies
From the heavens comes the rain
Carried by bolts of lightening
That shock the earth
Saying I am king of these clouds
I will die here someday
Like our fathers who said
Tread not on Freedom
To die in battle for this place
Would be Absolute Grace
Los Angeles area, Over cast. But I would welcome a lot of rain. Watching Midway. Doing a little DD on Oncology Biotechs at the same time.
. So first you based your short on a Head & Shoulder formation that never occured and you were way WRONG. Now you are basing you short on a potential delay. Well lets say you are correct. The company has till the end of the year to submit the NDA and that is way past your August deadline, Sorry, You lose again. Try again.