Just about a zero chance of this not being approved. If they have a problem with this they may just as well pull Tylenol off the market tomorrow. Never mind morphine and everything else they now use in hospitals. This is cheaper than what is used now and the FDA will approve it.
I agree with you but there is one guy (justwarning-u) who might disagree. His posts are really dump and some people are actually responding to him. Really guys stop responding to his stupid posts so they are pushed down. He keeps repeating himself and obviously has an agenda. Don't play into it, ignore him. As you will notice, he has only a small history of posts, that should tell you something right there.
I had been in APPA at .84 but sold too early. It is running into PDUFA, but I think their phase III did not meet it's goal, but still has a slim chance of approval I guess.
I was in on MNKD, but got out recently on the run up. I'm mostly in pymx, I think that could take a small leap once they announce PHII plans.
The prior November date for the PDUFA for IV acetaminophen was extended to February 12, 2010. If you go back and look at a chart, this climbed to around 11.50 and then dumped to 9 on the news of the extension. There are not many trading days left before the 12th. Also early news from the FDA catches folks off guard and can hurt a stock. (e.g., Look at DDSS today with its early FDA news. I have a bunch in the mid 1s so I'm fine, plus I believe it will be double or more today's price in six months.) My point is there are a lot of IF factors.
First, I am hoping for approval and think we have a very good chance since acetaminphen has its issues but this would be administered in hospitals with orders from physicians. Also, the FDA has a lot of problems with prescription pain medications and potential addiction. Not an issue with this.
Next, I am hoping that the news is timely, not early, in order to give this a chance to build/run a bit.
Third, based on the prior pattern and where we are today, I expect high 10s to low 11s next week.
I am not hugely involved here compared to some other investments and am in at around 10.00. I see this as making me 2 to 4 per share if approved with a down side of a buck or so if delayed again. If I make a little more or a little less, so be it. Profit is profit. At this moment, I plan to hold for the news. GL
What are your thoughts here on this?
I remember you from Spectrum, the only rational being over there last year with both the PDUFAs.
Do you think this will make run into PDUFA and if approved, will it go move up much?
How much of your portfolio would you risk? I am on board with you and believe the same. With approval this goes to $20-25. Completely safe and used everyday all around the world! I still don't like the way the stock is reacting, could be sector shift though
Obviously not without risk, a drug company with one prospect. If something calamitous happens we are all screwed. However, no one has ever come forward to my knowledge with even the slightest argument why this wouldn't be approved. Tens of millions of doses being given out across the world for years without a problem. Once approved I think it will spike to 15-16, and then settle in around 18-19 for a while with a hell of a lot of publicity for the drug. I have 8,000 shares right now and think that's plenty. My only real fear right now is that the date gets extended again because some bureaucrat somewhere didn't feel like coming in on a weekend and catching up on all the work they've fallen behind on.