The word "COULD" is all that resonated from your message! Many years of "COULD" has brought us back to start up prices! COULD you elaborate on How these tentative Catalysts COULD propel our pps and adoption, or COULD you give me other "COULDANRY" possible miraculous explanations! I COULD be open to a differing point of view!
Based on the responses of 2,062 industry professionals published in the Global Medical Device IndustryOutlook for 2016 by Emergo Group, Russia and China traditionally was most often cited as more difficult markets to enter. 58 percent of respondents consider that the process of obtaining regulatory approval for a medical device in Russia in 2015 became more difficult than before and only 2 percent of professionals believe that situation became better. Between January and September 2015 only 394 out of 601 new medical devices from foreign manufacturers were approved - 207 were rejected.
If the company has indeed obtained registration approval this month this would be one of their largest sales territories to date and a significant achievement. As a side note, INTENSIVMED are official dealers of Sorin GmbH heart-lung machines and PULSION Medical Systems SE both leaders in providers of cardiac surgery and critical care technologies, and with a large sales and network of sub-distributors that they cover the whole Russian Federation.
Hey Pears, I think you are working overtime tonight. Something starting to worry you? Maybe it's time to cover your short position. CTSO might open at 3.70-380 on Tuesday.
Sentiment: Strong Buy
Notice how many times you said "could" Greg?
Chan is a far better salesman than yourself.
What FDA trials are you referencing greg? Now don't be deceptive.
I asked some questions about the EAP and received this response from Dr Chan: "Thank you for your email. We felt that the EAP program represented a change in heart by the FDA, given the absolute lack of effective therapies to help critically-ill patients. There are many published articles by well-respected intensivists that have questioned the FDA's insistence on 28-day all cause mortality - an endpoint that no one has been able to hit in a pivotal study, with the exception of Xigris (that was then withdrawn from the market in 2011). As a physician, having something to offer a patient who is dying is better than nothing. We understand the FDA's skepticism on sepsis therapies, given the many failures in the past. But truth be told, many of the therapies that have "failed" in the past, likely had their place and probably would have found their place if given enough time. But clinical trials are often based on a "best guess" of what could work, and if you guess wrong, it could prematurely kill a potentially promising therapy. Also, the pressures to enroll a 1,500 patient trial quickly often leads to compromises in terms of patient selection that ultimately manifests in a dilution of the efficacy signal and a failure of the trial.
Although we have known about FDA's long standing stance on 28 day mortality and sepsis (which is why we are pursuing cardiac surgery in parallel), we had to try for EAP designation. Like you, we believe that there was a perfect fit and the acceptance of surrogate, less stringent end points could have been great.
In terms of other advantages to the EAP program, sepsis is already considered a disease that would get expedited review, so there is no advantage there. Our thinking was, if we had to show 28-day mortality for approval AND need to commit to a post-market study versus go down the traditional route that did not require a post-market study, the latter made much more sense.
Sentiment: Strong Buy
You are lying again pearsby. The rhabdo study is run by the Air Force. CTSO has no control over it's time line. Same with other studies. They are forthcoming, unlike you.
Surrogate end points are indeed very much included the comprehensive data collection to all approvals. Safety, Large "N", Double Blind, Multi-Centered, Definitive Surrogates, Primary End Points, Secondary End points, two large scaled P3 trials showing consistency with the previous P2's, P1 and Pre clinical data. This is the consummate data FDA package! It would be like the statins trying to demonstrate cardiovascular morbidity/mortality with out concomitant Hyperlipidemia attenuating profiles...NOT!!! Surrogates are the precedent to the FDA cause and effect morbidity and mortality for all disease states!
Data had nothing to do with it. If the FDA would not accept surrogate endpoints there is no point in it.A study with 28 day all cause mortality for sepsis wold get fast track status without EAP.
Sentiment: Strong Buy
The device was invented by a Russian, so it's a Russian experimental device in the hands of American capitalists. Let's hope Barack Obama doesn't impose more sanctions just as Intensivmed places a follow-up order.
Russia is on the brink of reengaging a new order of cold war and possible nukes. I am sure they want an American experimental device! Our medical/relational/economic and relational status is at a long term low.
It's the day after Valentine's Day and all the Wall Street guys will be too tired from skrewing their wives, girlfriends and mistresses to go to work and skrew us.
BTW. EAP is designed for unmet disease states...All septic patients are at extreme risk of morbidity and mortality! Yet after many years in the EU...NO EAP. The FDA sees no benefit with the anemic data brought to the table...very sad, very very sad!
To You and Love. I will not lose one blink of sleep over loosing opportunity to CTSO. ^ YES, Years of the same baloney and desperate this and that are coming around the corner...6 YEARS! Even if this pops to 8, most will still be at a significant loss, UNLESS, there are those liars who loaded up in the low 3's! I have heard about five new IP's, Dosing studies, Rhabdo data, CABG data, Trauma data etc... etc... Nada, nothing...Dream on as Chan baits you for more dilution and getting very close to another R/S!