We have seen how cigarette companies have derived systems of drug transfer through vapor. My guess is the delivery concept is intact. The true issue is Will the FDA approve the drug. Previous submission had acceptable results however the delivery tool, dreamboat? was introduced in the middle of testing. This is what was said confused the results. Being that the were not said to be a failure is seems that the new delivery system is better that the first. I believe it works. Will the FDA and other influences impact this is anybodies guess.
Will love to hear complete and direct discussions on topic.
my opinion is it will be approved..... the only things that need tweeked was the size of the inhaler to make it more convienent for the user... the stock price will soar.... everything is in place, sit back and watch!!!!!
Sentiment: Strong Buy
In my 50 years of investing i have seen many a sure bet fail, Just do not believe phase 3 results will be great or that there will be a partner. Testing thousands is one thing---going into production for millions could identify hiden problems that are not picked up in smaller statiscal sampling. price range between now and 1/15 0.50 to 12.00 depending on sucess or failure.
Please elaborate on why you "do not believe phase 3 results will be great or that there will be a partner." Or are you simply spewing nonsense? Not that a single investor should be concerned about what you "feel", but I would like to hear your rationale and conclusions that lead you to "feel" negative about phase 3 results and partnering prospects. According to every official announcement, comment, statement, filing from the company, prospective for approval and partnership is at it's highest probability level in history for the company. I beg to differ with your feelings. Now, perhaps you are figuring Motley Fool, The Street, Flyonthewall, Yahoo bashers into your assessment....then by all means, "feel" away....
Yes. But did cigarette companies have to go through FDA approval process? In theory, FDA wanted to simply see non-inferiority of dreamboat versus medtone. Affinity 2 goes directly at the label issues (will it include type 2). As far as I know, lung function and other safety is not in question at this time. If data is there and this does not get approved, something is wrong! One issue is how will they finance through the process? Not enough cash on hand so what source will be tapped....I do not buy into the partnership because Al won't sell out for less than 10x investment and I do not think he will get that via a partner. He wants to sell it as a viable company after sales have been generated so money has to come from more dilution. Excellent opportunities to add to your position. Let's pray it all works out. Otherwise, my wife is going to say, "I told you so!" Again.
ALXA has a "vapor" inhaler and it's already approved.maps pharma got its migraine inhaler approved and Allergan bought them.......all this in the last 12mths.mapp actually knew it was getting approved prior to pdufa, because the fda came right out and stated it was going to approve.....just a matter of what the label was to be....and boughtout before pdufa. some of these scenarios are likely to happen to mnkd.JMHO