" It only needs to demonstrate efficacy relative to controls " Really, did you find that on the FDA web site...I don't think so. So you think just by having a good side effect profile ITI007 will become First Line Treatment ? Please. As a Clinical Psych you don't prescribe drugs correct. My experience as an MD x well over 30 years tells me if you don't show ITI007 is significantly better than the existing Best Treatment Available (and sometimes even if you do) ie efficacy, then the companies that pay for the drugs will use that to DENY full coverage. When patients get to the Pharmacy window and are advised it is either a large "Brand Name " Co-Pay or a Full Price charge, patients chose a generic, like Abilify which works well for many patients. You are fooling yourself if you think Payers are that easy to deal with. For payers, the name of the game is bottom line and they know well how to manipulate protocols to keep costs down. It will be very easy for a payer to deny paying for a drug that has not demonstrated efficacy against the Best Treatment Available Generic.
resist. 45.88 2
resist. 42.19 5
Note IF ACAD can punch though $42.19 there is little to no resistance holding us back up to $45.88. Then we are in " The Land of No Resistance ".
Type Value Conf.
resist. 45.88 2
resist. 42.19 5
supp 40.30 8
supp 39.07 5
supp 38.21 4
supp 35.24 2
supp 34.76 2
supp 34.17 2
supp 30.98 2
supp 30.40 4
Note the next resistance level. $42.19. ACAD would have to cross that and nice to close above that-then we are talking $45. Otherwise, if it can't cross $42.19 then it might just sell off again. Just my opinion.
I think the movement of the sp is just as perplexing to the shorts too. Some shorts maybe moving out before we move to a higher level.
Well it would be nice if we get CEO news, but it really seems like a Biotech Sector POP. IBB up $11.
Well if we are into conjecture today...I think Uli thought he could submit the NDA then work on the Manufacturing arm / QA . The FDA takes 60 days to accept a NDA. I think finally someone ( perhaps a consultant or a member of the BOD) stepped in and advised the Leadership Team the FDA will not grant approval without the Manufacturing QA ready for review. Uli then pressured Davis and Mills to say they were "still on track". They lied. They had no guts to stand up to Uli, but BOD felt Uli put the company at risk (which he did) . The truth shall set you free, Uli was odd man out. Davis (and to a lesser extent Mills) is lucky he didn't get canned too. I am sure they put all the blame on Uli. Davis is not CEO material and if he is elected CEO I am not sure how it will be received by the shareholders.
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.