Synacthen - NDA hearing to kill it
Acthar - NDA hearing to kill the Armour one.
Questcor NDA filing - 'USE THE ARMOUR NDA, NOT A NEWLY SUBMITTED ONE'
Will Questcor need to start over with Synacthen, delaying their plans and possibly missing milestones in the Novartis contract?
If Questcor must use the Armour NDA and that gets killed because they didn't keep up with filings...?
Why did the gov't deny a new NDA and tell them this new one is only good for labeling?
and quite a few more questions that came up in my research that you should be able to formulate yourself if you stop jumping and start reading for context.
What does it all mean? No friggin clue... happy now?
Why don't he peddle his Krapolla somewhere else, he thinks he's da King of da Hill all by his Self.
Tells ya 1-thing does anutha, comes here & swears just one last post, lost credibility little like an Elf.
first, thanks for sharing good info. annual reports are required every year. i wonder if the listed "failed to report NVA's" means they are throwing in the towel. why continue reporting when you have no viable business case. why would Parke Davis fail to file a report? isn't it interesting that so many related NVA's are not reporting? just saying
There is no NDA hearing to kill Synacthen. In fact Synacthen is in early pre-clinical testing and doed not have a NDa with the FDA. It is only approved in Europe and certain other countries. Novartis still holds the European rights to the drug. QCOR bought the US rights, basically to block a potential low cost manufacturer from providing competition to Achthar. However, due to the sales agreement with Novartis, they will have to try to seek FDA approval, in the future.
This is from the initial report and clearly debunks the notion that Q has no rights to Synacthen other than in the US. What I would ask of Mike is if you have the material why not share it? As you have said it makes no difference to you because you are essentially out. However you did convince many people to invest in QCOR, some rather heavily. Why all the games? Supposedly most people here are pretty mature and not really bashers...maybe cheer leaders to some extent.
Under the deal, Questcor must pursue FDA approval, then commercialize Synacthen in the U.S., at which point Questcor will immediately take over U.S. rights to the drug. In addition, Questcor will also take over rights in over three dozen countries outside the U.S., subject to closing conditions that must be satisfied within two years.
"This key acquisition provides an opportunity to initiate our presence in more than three dozen international markets, giving us an opportunity to reinvigorate Synacthen in these markets and providing us a platform for potential international growth," Don M. Bailey, Questcor’s president and CEO, said in the statement.
Sentiment: Strong Buy
Mike, thanks for putting it out there. I know in the past you've mentioned some resources you use. In an attempt to streamline my DD can you share your standbys and subordinates. I spent two hours looking for details on today's short thesis and found only a fraction of what you provided.
Stick around. People should know that personalities are different. it would be an exercise in vanity not to have your expertise here...but if others want to cut off their noses off, their faces could look a little ridiculous. Stick around.
Sentiment: Strong Buy
Thanks Mike...maybe someone close to Patty can find out more details like Pharma. Ya know for people like me trying to learn as much as I can and hopefully make wise investment decisions, the bashing and hatred on this board has truly gotten out of hand. Seems like when the price dropped last week people's attitudes went in the same direction, truly there are so many GOOD people on this board. Just my thought.