Let's rate our leader Lewis....in the past month we withdrew from ema. Stock is sitting under a buck. Lawsuits which I don't believe will amount to anything but none the less don't look when your a ceo. Haven't said a word to shareholders in how long? Either there is going to some serious fireworks over the weekend with some kind of deal getting done entering the 3rd quarter or our fearless leaders job should be in jeapordy. I think he's smarter then that.
arikaycerocks • May 3, 2016 12:35 PM Flag
1users liked this postsusers disliked this posts1Reply
If you can't ignore him, why not put him on a starvation diet?
I'm certain he's far happier seeing his name mentioned than seeing a thread likely to catch the eye of new investors bumped to the top of the board - in one fell stroke rendering his spam posts a waste of time.
If you start acting as though he's invisible by doing that instead, he'll be reluctant to post more than a few times in a row for fear of losing face. Less
What is your expertise on this matter, terry? Care to respond to my well verified statement that treatment is staggered in clinical trials? You need citations? I got 'em.
I try to correct the troll on this board by responding to his posts, but he then deletes the post I respond to and then floods the board with spam. What a weirdo! My only point is that in most clinical trials, the entry and treatment of participants is staggered over the recruitment period. Think about it, where is the compassion in a scheme depending upon full enrollment for a start where participants are probably suffering and needing treatment ASAP? This troll wants you to believe that no participants have begun treatment, whereas, in reality, they could have started a staggered enrollment and treatment in January 2015 as verified by Insmed on clinicaltrials.gov. Man, is this guy is desperate and one loose nut.
No zake1 you are not terry, you just play on message board like terry. There is a difference, but you know that. Example:
"joe=no money and his Sherly
Have been legally removed from the other board. Blocked, and can not return. LOL
o carlerkornholer carlerkornholer • Apr 11, 2015 12:58 AM
What other board I post on IV as Zake1inchdick and posattny
o posnovotny posnovotny • Apr 8, 2015 12
What board? I have never seen either post here, what does a toatally different board have to do with Yahoo? Heard they both post on Investors Village but I am not a member as I refuse to pay for a board. If the statement you made turns out not to be factual it could be libelous.
Sentiment: Strong Buy
legalnotification legalnotification • Apr 9, 2015 8:16 AM
Ok,,,while it is true,,,sue me,,,what? you can't? Oh,,too bad...Joe...what a tool"
You're right, they show a phase 3 trial starting in January 2015, which it did, according to clinicaltrials.gov. You think they wait until full enrollment to begin treating? In most clinical trials, the entry of participants is staggered over the recruitment period. Think about it, where is the compassion in a scheme depending upon full enrollment for a start where participants are probably suffering and needing treatment ASAP?
Insmed's June presentation says 11 patients remained culture negative and 3 more patients were presumed culture negative because they couldn't produce sputum samples.
Proof of permenent eradication in only 11 of the 23 as opposed to 9 of the 31 non converters who also tested culture negative later.
" and then the trial begins "
Terry's current guidance / 2016 target:
" I warned these charlatans who know nothing about regulatory ... Insmed no longer shows a Phase3 trial starting in 2016 "
Insmed's current guidance / 2016 target:
" CONVERT is taking place in 16 countries and 130+ sites / Achieve screening objective in global phase 3 CONVERT trial "
Teflon Terry - NOTHING sticks.
Excerpts from the May 16 2016 ATS poster -
Of the 23 patients who achieved culture conversion by the 28-day end-of-study follow-up visit ...
... 4 converted at baseline (Day 1) prior to the administration of study drug
... 2 achieved culture conversion while receiving add-on placebo during the double-blind phase.
Of 7 patients who died during the safety follow-up phase, 6 had not achieved culture conversion.
Among patients with available follow-up SQS data (n = 48) data, those who achieved culture conversion during the main study were more likely to demonstrate negative sputum cultures at the 12-month off-LAI follow-up visit vs. those who did not achieve culture conversion (14/17 [82.4%] vs. 9/31 [29.0%], respectively).
As recently suggested, one of the Day 120 questions may have been along the lines of -
[ When it comes to an inhaled antibiotic rather than a tablet or injection, might not residual antibiotic in the airways simply be destroying the evidence of a pulmonary infection? ]
Of the 23 patients who tested culture-negative at the end of the main study, 26% had converted before receiving Arikayce.
Insmed apparantly hoped that data from the converters twelve months after the study had ended would prove that Arikayce had thoroughly eradicated the infection.
But given the evidence that the standard of care regimen alone had converted so many patients, perhaps the CHMP couldn't be sure of the extent to which the evidence of permanent eradication in 14 of the 17 patients tested had been compromised by patients having had to resume the SOC regimen during the intervening twelve months.
Fwiw the Phase III study has this secondary end point -
[ Proportion of subjects achieving culture conversion with durability after 3 months off treatment in the LAI arm compared to a multi drug regimen alone ]
Unfortunately that is what governments sometimes do and one of the reasons people are getting fed up with their total involvement in our lives. This whole EMA fiasco to me is outrageous. First you ask the company to apply based upon Phase II trial, let them spend all that money and then say Phase II is not good enough. Like you said underdog, there are so many good treatments out there for MAC patients, why rush to save a life.
That said, this is still just a temporary set back and Phase III results are not that far off. We just have to wait longer.
I AM acting in your interests. When he's in pretend-trader mode he's nowhere near as useful to us as he is in sour grapes spammer mode.
A few days ago we were inundated with "IMPORTANT STOCKHOLDER ALERT" press releases regarding ambulance-chasing lawyers that were trying to drum up business. They won't get anywhere imho .. but will we be receiving equally-attention-grabbing pr's when they give up on these bogus lawsuit attempts? I suspect not, but would be interested to hear if anyone's seen that kind of thing in the past.