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!