I tend to avoid biotechs doing research on hard to cure cancers, brain, lung and pancreas. CPXX - I have no clue, but its not something I would be interested in at this time. If you understand the science and believe in it then review the studies. Is there competition? do you believe management can deliver or is there another Uli in CEO position? Good luck.
I think the PDP % you mention is low..."As PDP occurs in approximately 20% of Parkinson's patients"... most articles that I have read & presentations I have heard say the amount of PD patients who go on to develop PDP is more like 40-60%- it is a major part of the disease complex.
What specifically was wrong with the data? The FDA..." did not believe the company's application had provided substantial evidence of efficacy to warrant approval ".
Hey who would have ever thought the CEO would resign and the QA Manufacturing was not "on track"... I got killed then, but hung in there and now...its our time...nothing wrong with a little anxiety, ...makes you run faster.
And drug insurance payers aren't stupid. In a short time they will figure it out. ...It's cheaper to pay for 30d of Nuplazid then just one day of hospitalization for psychosis. Once doctors get a little experience with Nuplazid the off Label use will start to rolling in.
As a guess, I would say is he is feeling anxious about a possible negative out come. He has a lot riding on the Approval, So what.
Personally, I am 99.9% sure Nuplazid gets approved. And here's a tidbit for you ...you don't owe me any apology.
I guess you didn't understand my post, I said have some RESPECT for his help through the years on this board. One post that you don't like will never negate Spaders help to the board in the past years. You can't see you are off base, but you are wrong. Have a nice day.
Perhaps the CEO knows the MRK sp will take a hit soon. So why not sell now.
""Kenneth Frazier (Insider Trades), CEO, president and chairman of Merck & Co. Inc. (MRK), sold 131,040 shares of the company on April 14. The average price per share was $56.11 for a total transaction cost of $7,352,654. ""
All insurance drug payers will attempt to decrease the number of prescriptions written...by charging the Brand name Co-pays & protocols...sometimes the Rx is only filled if the Pharmacist can verify the diagnosis, ie, that its not off label. " Pharmacy Police " ( I just made that up). All these tactics will decrease the Rx written for a while. But all these tactics will slowly weaken esp if the side effect profile is good. Remember, Nuplazid will be the ONLY drug indicated for a terrible condition and does not worsen their PD. It will be extremely difficult to deny the only drug indicated for one not indicated with riskier side effects that will most likely worsen their PD. Many times the Rx is given at night in ER's or Urgent care clinics. If there is no good option available the patient is hospitalized. So would you rather pay for a hospitalization ( cost more than the Ritz Hotel) or give them a 30 day supply of Nuplazid?
I don't have a problem with it. These black box warnings lose their shock value once doctors get use to using the drug and see their patients responding well with little or no side effects. Then off label use will start to pick up.
richinjun, have a little respect. ACAD has made me pucker a few times too...when Uli dropped his retirement on us and the QA was not ready, I held all the way down,,,it was painful. similar to being kicked in the nuts by a size 13 boot. Anyone who held through that and is still here is a true believer. And some new folks here may not know Spader, but those who do know he is the go to guy for those really difficult questions we have had through the years.
Whatever, its the safest drug and the ONLY drug for the indication of PDP. It won't matter, the FDA will not be able to prevent doctors from using the drug off label once it gets rolling. It's coming down the tracks.... and there's not a dame thing the shorts can do about it.
1) Over whelming APPROVAL for the treatment of psychosis only in treated Parkinson's Disease patients.
2) A post Approval safety study will be conducted.
3) A Black Box Warning - " WARNING: DUE TO INCREASED MORTALITY IN ELDERLY PATIENTS, Physicians are cautioned to restrict use only in patients currently being treated for diagnosed Parkinson's Disease who develop psychosis due to Parkinson's Disease ONLY. And only when the benefit of treatment out weighs the risk of the listed side effects including death. " Off label use of Nuplazid has not been studied and is strongly discouraged due to placing the patient at undue risk.
Not sure why you are "pretending" to own anything other than what you really own. You are feeding your fear. FDA approval has absolutely nothing to do with luck. We have waited a long time for this day and an now its just around the corner. AdCom gave us a huge edge on a positive FDA decision, why don't you pretend you are Babe Ruth, you just let the pitcher throw two perfect strikes and now you are pointing to center field....don't give fear the advantage...you have been in this stock a long time and you will surely be rewarded.