It's really incredible that a company withdrawing their application to get a drug approved has turned out to be the happiest day of your life!! Since that day you have posted all day long every single day, non stop, in an absolutely giddy manner. Happiness steps up to greet everyone occasionally, and you are so happy that now must be your time! Keep posting and thumbs upping yourself - it ain't gonna last....
Thanks, I find that really interesting. I'm not sure how that may be similar to Arikayce, but it is certain now that orphan status can be revoked. Of course, at least here in the U.S. AIDS at one time was an orphan disease, which became the reason President Reagan signed the orphan drug act into law. Perhaps NTM is becoming common enough not to be considered orphan by the EMA? That's just a wild, likely incorrect guess, but there isn't a similar drug approved...
Jad, I don't necessarily disagree that it often seems like Insmed leaves shareholders guessing, but the recently filed 8K at least addresses the three issues that you mention: The company is supporting compassionate use programs in France, Germany and the Netherlands and soon Italy.... I'm not sure that any company would give an actual number of patients being treated, they plan to resubmit the European application when clinical data from the ONGOING phase III is available, so it's not yet available, and they actively seek licensing opportunities (partnerships) for a broad range of rare diseases - apparently that active seeking hasn't yet materialized in a partnership agreement.
I suppose more detailed info would be nice, but I dislike it even more when companies deliver some type of "fluff" announcements on a regular basis.
Now the question that you brought up about the 6 month results could prove to be the key to the whole puzzle, since the 8k clearly states that the application will be refiled with the MAA when clinical data from the ongoing phase III trial is available. They didn't say when the trial is finished. They didn't say when the trial is fully enrolled. They said when clinical data is available which any honest person knows will be long before the trial is finished.
namxorex, while I agree that purchasing just for a buyout is often a good way to dwindle ones net worth, when there is a sudden explosion in call option volume as in today's July 10 contracts, it certainly seems to indicate that bets are being placed on a takeout. I haven't followed these shares for long and would not even attempt to handicap the odds of that happening, but over 1700 contracts all right near or at the offer makes me feel like it could happen.
"Perhaps, the less we have, the more we are required to brag."
- John Steinbeck, East of Eden
"Those that lack any true accomplishment, simply make things up."
- Bohemianclubman, Yahoo message board
"The great wannabes of the world may spend their entire lives on useless tasks."
It's a mystery. Many years ago I went each summer to Ojibway Provincial Park in Ontario - any connection to your ID?
Retail sales were out today, with restaurant sales leading the way. An IPO of any of those three could happen sooner rather than later.
I'm not sure about that rocks, I don't think I remember an orphan designation being taken away. Arikayce still has an orphan designation for Non CF Bronchiectasis I believe
I don't like you Terry, but I don't wish harm on anybody, anywhere. The way that INSM share price has held since withdrawing their EMA marketing app has me worried that your anger has swelled to the point where your head could explode. I look at your many posts today and can almost hear your brain screaming WHY ISN'T THIS STOCK AT 6!!!!! Why has it only fallen a dollar? Why?
Thanks French, I do believe that baycapital is correct when he says that Wendy Moats will be a game changer. Leaving 80 Billion market cap SBUX to come over to 50 Million market cap RAVE only makes sense if her package includes plenty of stock options, along with her belief that moves are available to greatly appreciate the share price. I'm fairly certain that giving den56 a call for suggestions is near the top of her list. BTW, 10000 store SBUX showed a nice increase in SSS last quarter which they attribute to surging food sales. Interesting.
The story did not mention EYES but spoke of the Argus device and the way it restored hope in an Ohio man. Since they did not mention the company by name some may have to do a Google search before they can purchase. Since the story is likely to be repeated on the evening news an even better pop is possible in the a.m.
100% agree Baycapital, and the 130 thousand plus shares trading today are investors that grasp the fact that a young company like Pie Five can be turned on by a single motivated leader. When the news was released yesterday, and I read her resume from Starbucks, I felt.....much better....
Thank you jjkimo, I had not seen that before, but have always felt that if iPLEX can prevent blindness in infants it obviously is powerful and will eventually have other uses. Even though that scientific report is from 2014, it is nice to know that IGFBP3 can also cure cancer. I'm anxious for the arikayce decision from Europe. I'm anxious for the phase III here to be fully enrolled, and most long term Insmedians (Insmeders?) are also looking all the way out to 2018.
It seems obvious to me that INSM was seven years early on their muscular dystrophy trial. The mood at the FDA has shifted so dramatically regarding these hopeless types of disease with absolutely no cure that compounds with no proof of benefit are making it all the way to the regulatory agency's decision table. The EMA turned down BioMarin yesterday, and the market is concluding that it will now be easier for the FDA to turn down SRPT despite the protests from desperate parents, but it never should have gotten this far. A simple Google search will show that iPLEX at least showed some benefit to MD patients in it's 2009 phase II trial, and In My Humble Opinion iPLEX would now be a cinch for ALS. btw, I'm hoping that a local bank stock gets inclusion in the Russell and this year the minimum market cap appears to be around 150 Million....
For a company that has a pretty good chance to gain approval for a product that will offer up some competition to a billion dollar product.... I can't believe how low the volume is. I expected the volume to surge this week but have been very, very....wrong...
I think that since all option orders must have opening or closing when entered the open interest is updated right away. I guess that I wouldn't want to state that as a fact, but feel about 85% confident that the OI is updated with each trade.
b_leaguered, those look like call options that were purchased to close a position since the open interest after a 2663 contract trade is now just 10. That is a 350000 trade that appears to be someone that doesn't want their shares called away at 12. I find that comforting. BTW, thanks tom, I hadn't been watching the options today
You didn't even understand his post and he owes you no apology.... you are alive and in November we will celebrate those that made it home