"culture negative" and with the presentation coming soon, I added 120 shares today. Bios are getting run down the last 4 trading days so it is time to buy again. Added to three bio stocks today alone. al
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.*
Historian, you have to give Terry credit, he is persistant in wanting Insmed to fail so that people will continue to suffer. He is a remarkable, but sad human being!
It does remain to be seen how all this plays out......but just to correct the record slightly.....the settlement was March 2007.....which just proves an age old truism.....that time indeed flies faster the older we get........LOL
Blased, you make some good points. Let me ask you a question......and I certainly have no idea about it myself.....but based upon a couple of your comments, is it possible that some of the job opportunities that Insmed has been posting could serve a dual purpose to meet the future needs for Arikayce....AND iPlex??
Let Terry work his fingers off today:
If you were a business and were getting ready to sell a product or service in a new market on September 1, I doubt you would fly by the seat of your pants to begin marketing the new product or service on August 31. You would determine the cost of making the product, advertising and marketing, getting a sales force or customer service team together and making sure they were knowledgeable of the product and/or service. In addition, you would have to know how to distribute that product in an efficient manner, or how you were going to efficiently produce that service with knowledgeable employees. You might need a lead in time of 6 to 12 months to properly plan the rollout. (This is all similar to the possible European rollout if Arikayce is approved)
The same goes for Iplex. whether or not it's Insmed, a partnership with Insmed, a licensing agreement with Insmed, or an outright sale to another drug company, a lead time would be needed to jump thru any regulatory, manufacturing, marketing, and distribution of the product. My guess is that Insmed does not wait til mid 2018 to do something, as there are patents that have a limited life of protection, and Insmed will possibly have something to say about it in 2017. Iplex has already been approved. A court settlement put everything on hold. Some entity will want that drug!! Hopefully, we will see how good a businessman that Will Lewis is. My bet is that Will Lewis has had discussions with entities that have interest, and that a select few know the value of those discussions, and what it could be worth to the company. If he has not had those discussions, I would consider him not a good CEO, but his financial background and previous drug company exposure taught him due diligence. So we will see!!
Three threads with relevance to the "Arikayce secret agenda" theory :
Why did the EMA block a breakthrough therapy?
Why approve Arikayce for more than NTM?
Do the NTM data support approval for TB?
Worth a try. The most I've ever known Yahoo to do is to delete an account under which TOS violation has occurred. The culprit is usually free to promptly open a new account.
But it seems from that complaint that the terry_insmed alias belongs to his main account. If you can show Yahoo proof of blatant disruption of the forum via that alias, there's every chance of him losing that account.
If everybody takes 5 minutes and hit the report abuse button from certain of his posts, it might help slow him down. I wouldn't bet it will stop, but it will make him work harder in his high paying job!!
some people just can't do it. All of these posts referencing terry are as bad as terry's posts, I guess they don't have a life either.
Well, I just wish Yahoo would pay attention and get this clown under control. Apparently he has some luck getting them to act a few years back. Time for me to pester them and see what happens. Fyi. I went ahead and started grabbing most of his idiot posts, gay posts, etc. I have almost 60 of them. Time to start sending them over to Yahoo and see whY happens.
Sentiment: Strong Buy