IF (still a big if or at least a regular *if*..) EMA gives Marketing authorization approval, it's sort of a no-brainer that Arikayce will be prescribed off-label, especially with all of this type of data...right?
Good to see this pr. These posters will provide some very interesting reading when they're public for sure.
nice reading this below again in the most recent 10k too...
*the protocol for the convert study incorporates feedback from the fda and the ema via its scientific advice working party process, as well as local health authorities, including japan’s pharmaceuticals and medical devices agency, and was approved in the us by a central institutional review board (irb). We initiated the global trial in early 2015 and expect to complete patient enrollment in the second half of 2016. If the convert study meets the primary endpoint of culture conversion at month 6, we believe we would be eligible to submit an nda pursuant to 21 cfr 314 subpart h (accelerated approval of new drugs for serious or life-threatening illnesses), which permits fda to approve a drug based on a ‘‘surrogate endpoint’’ provided the sponsor commits to study the drug further to verify and describe the drug’s clinical benefit. We believe that efficacy data from the convert study after month 6 will suffice to meet this commitment. We are currently conducting convert at over 115 sites in the us, europe, australia, new zealand, asia and canada. The convert study is designed to enroll enough subjects to ensure at least 261 subjects are evaluable for the primary endpoint at month 6.*
It is a shame, indeed.
Civil, rational debate and the exchange and evolution of ideas is actually part of the enjoyment of investing. Yahoo hasn't done a good job here, beyond some particular glitchy software.
Insurance reimbursement, aside, one would have to assume that off-label Rx will occur as well, right? (I am jumping WAY ahead, obviously.)
Ummmm, not a *do over* but the Primary endpoint of the Phase IIB failed and the Scientist that was running the trial was fired and then Management did indeed botched the timeline to investors and had to correct which wasn't good at all ($$$), if you remember!
Full Enrollement now scheduled for the end of this year...maybe we get good news that it is enrolled sooner, though.
You do realize that Mr. Dreschler has lead these Presentations solo before, right?! You, also realize that you're being as dishonest and fraudulent as the *shorts* and their prognostications by making up this *idea* and publishing it, right?!
How about we get just get some dang positive news from Management that has spent a 100 mil in the past year about Trial Enrollment, Partnership Money (anyone else remember Mr. Lewis numerously teasing the Japanese Partner talks 2 YEARS ago?!) and LEGIT EMA news that is honestly revealed...PUBLICLY?
It's been a VERY long time and enormous dilution for Common Shareholders since Geoff Allan's success, that's for sure. I could care less about anonymous Message Boards p-contest that hurt so many insecure feelings but I do hope for ONCE this Management Team/ BOD can actually close the deal and create meaningful value for common shareholders and not the traders and shorts that have continually feasted on their mistakes...for years!
JTFM, I hope your intuitions for a *Libigel* deal are correct but I wouldn't use disappearing post on this MB as that obvious of a clue....for anything. Disappearing post happen constantly for every name I follow and readers seemingly always jump to the same conspiracy theories of malfeasance and *great things just around the corner....*
These MB's have been glitchy and an algorithmic mess for years. I CAN see bored, desperate Day Traders clicking the *Report Abuse* box frequently, though. In this case, who would care? The stock has been beaten and weak for several months now. A buyout is one thing but what would a *deal* for Libel even have to do with the stock price?
Not being argumentative just ruminating as the stock withers.
And Management has known this ALL YEAR but waits to DILUTE loyal shareholders at all-time lows.
They are either completely incompetent or they have no soul.
And much shame on Al Mann for not having the very best leading this great drug.
Anyone remember all of the Insider Sales this past year? Diane Palumbo LIQUIDATING?!
So, how many more Rx's will we NOW need in 2016 to justify a respectful PPS for long suffering supporters AND so these jokers won't have to dilute AGAIN a year from now?!?!
Heck, now we need a minimum 13% jump in sales RIGHT NOW...TODAY, just to make up for the dilution we're getting this week.
Whoa, whoa, whoa! You're not suggesting that our former Hedge Fund CEO might actually still have a friend or two in the industry are you?! Noooooooo. Never! This altruistic soul is giving us yet a another *buying opp*. Better hurry, though, before that $1000. PPS buyout lands!
It all comes down to the EMA now and If things with the EMA don't go smoothly, than what? Another buying opp and just wait a couple more years! Woohoo!
(I know, I know. Everything is perfect and I should never question this Slam Dunk Company.)
Our former Hedge Fund CEO got burned on Gupta's Trial Design and now over his head with new trial enrollment. The boy certainly knows how to raise and spend money, though, eh?! Now it all comes down to the EMA. Freaking lovely.
I'll now anxiously wait for for Zake to tell us how the bankers/insiders happily have shares at a higher price and that he's gratefully buying with both hands! It's only then that we will know things in Insmed Land are all normal and A-OK!
Something related to LIBIGEL right around now would be very nice and helpful to our valuation. No denying that the EEMT miss and future cloudiness is pretty disappointing. It's also a harsh reminder that the space we're in (generics) is ultra-competitive and constantly evolving. Throw in the fact that many/most of ANI's acquisitions are in a slow-motion route to being accretive and the related revenue is a moving target.
Biowatchdog, Do you think this is just Management being fastidious to ask for the June extension or is it possible the LoQ are complicated enough that they feel that they need all the time they can get? Theoretically, getting that *early* extension is sort of the only way Management could also accelerate the review process too, though, right?
A PR from headquarters, upgrade from analyst or even a *note* from Insti would be great. Either way, excellent news from the Poster Presentation!
A buyout doesn't allow Management/BOD a perpetual gravy train either. Lewis has plenty of money and was a Hedge Fund guy for years so who knows what his long term goals really are? He does seem passionate about CF/NTM and making positive advances, though. But raising money to buy more IP right now seems insulting to common shareholders unless it's an immediately accretive asset. For heaven's sake, get Arikace on the market already! How many years since the Rat debacle....five?! Sheesh...
Bio-tech is hands-down the hottest sector in the market right now and seemingly every BIOTECH has a B/O rumor attached to it. But more importantly, Mr. Lewis said that WE would probably be buying another company before Y/E so this *Buy Out* rumor could just be $$$ for those that would be front-running the potential deal. Cookie-cutter Wall St. stuff. Having said this, you can't help but enjoy the increased valuation whatever the case.
Genuine or not, I'm surprised he doesn't have Shire on that suitor list. Maybe they've already spent their allocated acquisition money but they should/would be in on a potential Insmed B/O, in my opinion.
Yeah, good to hear again but many, many years away. Everything is very slow going now...except for cash burn! These guys need to pull-off a Partnership while things are moving in BP/Biotech! What ever happened to Japan?!
I wonder if presently in Europe or if we do eventually get an FDA Approval for either CF or NTM, if this will validate to the point of allowing us/them to bypass full Phase Clinical Trials for other Liposomal attached Medications?