Compared to ACAD- several of those listed are over $50/share, the others are in a DownTrend. Good luck, you must be losing your bung on XLRN, KPTI.
What is needed is a new P3 study, double blind (+/- cross over) with the best dose result of the current P3 study, Head to head with say eg, Abilify vs ITI007 vs placebo with appropriate doses. Then you have your answer in about 8-12 months. It will not just show the side effect profile, but the efficacy as well against the "best" treatment available.
Is the efficacy of ITI007 better or worse than Abilify? If so by how much?
Then the FDA(and insurance companies who pay for the drugs) will have little difficulty approving ITI007 for a first line treatment if that's what the study shows. Otherwise there is a risk that the FDA approval will be something less than expected or be forced to do the new study anyway before drug approval.
Will it show a good side effect profile, most likely, but with only a single drug challenge to one older drug presently used that is not best in the Class I don't see the FDA giving a ITI007 first in line drug approval. Either something less if it gets approved OR not approved and ITCI will be asked to do another study.
"" Randomized, double blind, placebo and active controlled , in patient trial (N 500) Four treatment arms, 6 week treatment duration, QAM dosing 60 mg ITI 007 20 mg ITI 007 Placebo and Risperidone ""
Risperidone was approved by the FDA in 1994. I don't think that's best in treatment class. And no mention of more recent drugs like Abilify (Approved 2009,generic available) and all the others- Geodon, Invega, Latuda, Saphris, Seroquel, and Zyprexa. I believe they will show better results regarding the side effect profile. But do you think its enough to just do a Risperidone challenge? I mean its kind of an old drug.
The TRIAL: Phase 3 clinical trial (ITI-007-301) = "" In this trial, 450 patients were randomized to receive one of three treatments: 60 mg ITI-007, 40 mg ITI-007, or placebo in a 1:1:1 ratio. ""
My thought on this trial is... too bad they are not doing a trial against the best drugs indicated or currently used...I mean their competition is vast and not one of those drugs is mentioned in this study.
" Other atypical antipsychotics include Abilify, Geodon, Invega, Latuda, Risperdal, Saphris, Seroquel, and Zyprexa. Another atypical antipsychotic, Fanapt, has been FDA-approved for acute (but not long-term) treatment of schizophrenia. The use of all of these medications has allowed successful treatment and release back to their homes and the community for many people suffering from schizophrenia."
But no mention of any other drugs in the trial. Why is that acad4sale? How do they expect to get FDA approved for first line treatment or 2nd or even 3rd line treatment if they don't provide the FDA with that information ? I have great respect for you and know you are a smart person and can give me a reasonable answer.
Personally, I don't read much into that sale as you said, but if you see more insider sells at a lower price I would be concerned.
Several posters felt free to PUMP itci on the ACAD MB - So that brought me here which I feel I am returning the favor by just showing an opposing view backed up by my years of experience and TA knowledge...validated by today's BIG DUMP. Anyone not involved in ALL the info fundamentals and Technical Analysis on ANY stock has no respect for their investment. And I don't give a rats #$%$ if you respect me or not, so please don't try to patronize me with your respect for my service. You can not take away my dignity.
Why don't you follow the TA? I don't get it. Its right here on yahoo FREE. Then you would have realized the stock was close to its previous highs where it FAILED to break already TWICE. Not sure why you think this is some kind of unknown reason...the "something going on " is you don't follow the TA.
The company might even be SELLING - the only thing that might be a "saving grace " here is the volume is not higher. If it was this would really tank.
LOOK at the chart. LOOK at the indicators....Over Bought Stock with low OS and already failed to break the highs TWICE in the recent past with just low - moderate resistance...all adds up to SELL. If you didn't follow the TA...shame on you.