My question likely won't even be seen now by the one that posed the question. About a dozen peats and repeats came in and quickly buried my post. Oh well, somethings don't really change
"What COULD the EMA be evaluating?" I am sitting down, trying to think intelligently what the answer to your question could be, but I'm drawing a blank. Perhaps years of actually reading this board is beginning to dull my focus. What is your theory regarding the amikacin application? Is it something new from somebody else?
This product if approved one day would be used to treat PAH, IPF, Severe asthma, and sarcoidosis - something that was frequently misdiagnosed on the tv show House. Zake got me thinking that there really hasn't been anything new to discuss on this board, and many are tired of reading about charts and percentage gains, and other nonsense.
On Insmed's latest 10Q they state that phase I results for INS1009 will be released at a medical meeting in the second half of 2016. My guess is that will be the International Vascular Biology meeting Oct. 30 thru Nov. 3 in Boston. 1 because it is titled a meeting as opposed to a conference and 2 because it's somewhat nearby in Boston.
Probably nobody really cares, but I just had an inkling to bring up something sort of new.
Zake, I don't care about his trades either, although it looks to me that the point of the post was that he really has no trades.... That said, there isn't much to say about Insmed right now except that it would be nice to see a full enrollment announcement before December, and phase I results from their PAH trial. I realize that all the comments to and about him don't make this message board that he has pretty much ruined any better, and I have been staying away because my personality makes it difficult for me not to respond to idiocy. I do have a call in to Susan Mesco to see if she can help me better understand one question I do have regarding any reports we might be expecting regarding the phase III trial. I still subscribe to Investors Village and I wish all decent contributors did also. Over on that board you can actually call, talk to a person, and they will monitor the board. More importantly, there is a monthly fee so multiple ID's would be costly. I realize that you own plenty of shares, but so do I and occasionally I will still point out his lies simply because sometimes there are new visitors here that should know the truth.
I saw an ad on television for a birth control device that names possible side effects. They were numerous, and included death. I find it incredible that a birth control device that actually names DEATH as a side effect is approved and on the market, but arikayce which in a real clinical trial cured 300% more patients than SOC alone, is still enrolling for IMO a not even necessary phase III trial. I say incredible, but believe that word could be substituted with criminal.....
Well, it would be even more concerning if stores were closing, and none were opening. I don't think the shares could be purchased anywhere near these levels if the company wasn't having some hiccups, but I was a buyer once again today based entirely on the premise that moves are being made to right the ship, and good news will lead to a huge percentage move with this one. PE getting involved in some fashion as some here have mentioned certainly would not surprise me
Well, I think that they can make any announcements during blackout periods...... They just can't buy or sell shares
There sure wasn't an announcement, I had to go to the Pie Five location site to make sure it opened. I can't say for sure, but my guess is that of all 90+ stores that have opened that was the first that had no PR.
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.