Officially starting Elagolix phase IIB trial in UF which is a big deal to NBIX stock; and this up treand will be continued to VMAT2 phase IIB result reported - which will cauase either big jump or collapse based on binary event
You are comparing apple and orange, KERX's phase III cancer drug candidate did not even show efficancy, and Relistor is approved drug, and its new indication is supported by strong efficancy and safety...
When opioid receptor blocking medications were given, the growth and spread slowed.(Relistor is opioid receptor blocker)
This happended after Q4 CC, and those analysts had to change their numbers because they will look like fools after relistor inidcation expansion approval.
Also, I talked to the company's representive last week, just knowing the idea/approach to start with advanced patient indication then chronic indication was FDA's recommendation to PGNX. Now, relistor has been on market for 4 years now, and there had been no safety issue directly related relistor usage, and one year chronic pain safety trial result was very good in both efficancy and safety. We have no reason to not see this label expension approved on time.
Just a little bit more than a month to go...
Good luck to shorts because they really needed this time around
WHO said that there is no such wall which can keep a secret inside house?! The latest uptrend has everything to do with UCN2 topline data leak, of course, and promising VMAT2 phase II trial topline data in less than two months.
How many people realy belive in UCN2 phase II trial successful? A few, not even the management, otherwise, they would have rushed to secondary now...
VMAT2 development speed is going to change from the city street speed into free way speed soon, and it will be fun...
VMAT2 will be a approved drug by earlier 2015 or sooner if there is no safety issues(its efficacy will be approved in next two months)
Under Mr. Baker, PGNX investor relation department has cut all previous three personals, and one of them was VP. Right now, PGNX has only one part time consultant. Cutting unneccessary cost is a key to operate a company effectively.
The previous CEO, Paul Maddon, was a joke, he really did not know how to run a biotech company, never cared to communicate with investors for more than TWENTY FIVE years
Lazay boy, here are hight lights:
1). UCN2 phase II trial was completed last week, topline data will be reported later Feb or earlier March.
2). 32 patient VAMT2 phase II trial completed its enrollment, topline data will be reported before the end of March
3). VMAT2 program itself is a pipeline, preclinical data has shown it is was as effective as haloperidol is to treat Schizophrenia, Gorman was certainly more confident in his VMAT2 program future now than before because he must knew the ongoing trial site patient positive experiences; otherwise, he should only pump the VMAT2 program after the current trial is completed
4). Elagolix phase III trial will happen quickly - that is Gorman's original statement, no particular date was mentioned by him.
My prediction is THE TRIAN is going to leave the station before the end of March
Those barking morons will not have a minimal paid job here if you don't response to their garbages. There is nothing here could be influeced by sub high school educated garbage posters.
Promising PGNX's future has nothing to do with short term trading pattern period
Relistor chronic indication approval is the MOST IMPORTANT EVENT EVER to this company; oral relistor will eventually be a blockbuster drug with relistor chronic indication approval next April. I have a great hope for relistor chronic indication approval because Salix's partnership was based on completed relistor chronic indication phase III trial results.
You have to be here another 6 months for FDA verdict
News release has to be after the presentation which was done at 11:00AM today. It will have press release later on today...
I talked to company today, oral trial is as JP said 12 weeks plus two weeks prescreening and two weeks following up. The trial will be COMPLETED in ONE YEAR or less.
The company is hopefull that SC relistor chronic safety trial data could be used for oral.