Type Value Conf.
resist. 34.76 1
resist. 33.86 3
supp 32.97 2
supp 31.41 4
supp 28.29 7
supp 26.26 3
supp 25.00 2
supp 24.32 3
supp 23.09 4
supp 21.45 2
supp 20.47 5
supp 18.52 2
You are Ignored...The bear just ate you , later gator. Sorry, little tolerance for dimwits.
Consider if one injection treats a patient who previously manipulated their meds, stopped them for whatever reason, eg, left them on the bus, "my girlfriend stole my purse" ..."the radio told me to stop the med"...etc. Believe me its competition. One injection will treat patients for 90 days, thats only 4 shots per year. It is ideal for the condition. Are you under the impression that ALL meds for Schizoprenia are dropped by the patients due to side effects? You are very wrong. I had many patients on the same anti-psychotics for years and usually if they get an exacerbation they get a second drug added on. ANY product that treats Schizophrenia is a competitor- especially a new 3 month injection-this will be highly used when patients have a history of manipulating their meds.
All those patterns usually require a following day confirmation. - here the pattern was not confirmed so far today, ACAD has great momentum here. They are only chart patterns.
That would be nice, I mean how long does it take to hire a frigin CEO? the NDA I understand takes time, but a CEO...oh man what is going on with that?
When Pima gets approved, you will see - its a Rainmaker. ITCI, doing well too, looks strong, good product. I call it a" buy, with the caution " that the drug approval could be not what you might expect due to the limited P3 study only compared to Risperidone vs ITI007.
ITI007 will be an excellent choice for patients. But what will be the indication approved by the FDA? - they will only have one study to evaluate, ITI007 VS Risperidone. Thats it. I will be very surprised if ITI007 gets a First Line approval. This is the time ITCI should be announce a head to head study with one of the newer Second-generation antipsychotic's, eg I would say Abilify/aripirazole is your best bet. You want to show high efficacy and low side effects. others:
olanzapine and fluoxetine Symbyax
NUPLAZID/Pimavanserin is ONE OF A KIND, FIRST IN ITS CLASS drug to treat Parkinson's Disease Psychosis (PDP). And ACAD owns the World Wide Rights to it. The FDA has already reviewed the Phase3 research data and given ACAD thumbs up to proceed with the New Drug Application and has given Pima " Breakthrough Therapy Designation " USA sales will be over 1.1 BILLION and European Union will be well over a Billion as well. There are several other ongoing studies.. The manufacturing arm of the NDA is getting the close attention it should of had last year- it will take some time for new directors & CMO 's to get the systems ready & on line for the FDA evaluations. ..Review the catalyst list-
1) New CEO who can led us to Drug Approval and move the company forward.
2) Possible Partnership with a MAJOR drug company that will assure the NDA will meet and exceed all the FDA standards.
3) NDA on track to be submitted in the 2nd half of 2015. NDA is complete, manufacturing quality systems on track.
3) 60 days for the FDA (Food and Drug Administration ) to accept the application by about Q1 2016.
4) Upon potential acceptance, FDA could also grant priority review.
5) With priority review, six months pdufa date (Prescription Drug User Fee Act ), without, 10 months. Best guess is July to Oct 2016.
6) EU ( European Union ) filing 6- 9 months post FDA filing. Perhaps Q2-3 2016. Large unmet need in EU.
7) ADP enrollment (019 study) complete by 2015 Q4 and data by about Q2 2016
8) Schizophrenia maintenance trial to commence 2nd half of 2015.
9) Sleep Study to begin 2nd half of 2015.
There are NO ongoing issues with the FDA.
IDRA....Gee, I would have to say first just looking at the chart it is way down... the down trend is now a sideways move. Just that alone says stay away. But if you look at their R&D seems like they are only in P1/2 for RARE diseases. I don't like that sector in biotech. I was a physician, a GP, for well over 30 yrs and I think I only saw maybe 1 case of Waldenström’s Macroglobulinemia, maybe 1 or 2 cases of Diffuse Large B-cell Lymphoma, zero cases of Dermatomyositis and 2 cases of Duchenne Muscular Dystrophy. But here's what happens as a GP. You fall off your chair when you see the very abnormal lab or xray and promptly call the Oncologist (or Neurologist) on call. She/he will direct you what other tests to order and see the patient in follow up. You never try to diagnose these types of cases without a specialist input. That is can be a grave mistake. So sometimes you don't find out the diagnosis till the specialist sends you his or her follow up impression. You could go many years and never see these types of rare diseases. So stock wise IDRA does not meet my BUY criteria - 1) TA is a SELL 2) No P3 study-The A-F Rules says a biotech company in this MK range has close to a zero chance of a successful P3 study which they don't even have (only CTIC has broken that rule) 3) Rare disease may not bring in big revenues. I will tell you what I like better...is ARRY- great pipeling and excellent results at ASCO.
Nah...I think it was that Zacks article may have spooked a few weak hands... I would never buy or sell a biotech because of a Zacks rating. My broker has a " D " rating on ACAD. Their criteria does not take into consideration the science, pipeline, potential, TA ...etc. They are all about numbers.
Looks like there is plenty of money to go around...." From April 2013, through March 2014, sales of Abilify (official name, aripriprazole) totaled $6,885,243,368 ".