Barry,
Not exactly sure what to tell you right now. There are many ways this can go. There are multiple questions:
a. The saturday san diego union tribune made a certain point clear by way of ATIS. The bulk of the article had all kinds of opinions from analysts, etc., but the last two paragraphs were:
"Despite speculation from some analysts, Benvenuto(ceo for those who don't recognize this name) said the manufacturing issue had not been a factor in the FDA's decision. Rather, the agency had been unsatisfied with some aspects of ATS's data.
Primarily, the issue was "retrospective analysis," a technique ATS used after changes in its study's design became necessary . It is a practice the FDA discourages, as some believe it can lead to biased results."
Obviously, the implication is that the main issue to the fda is that they didn't want to set a bad precedent of approving something by way of retrospective analysis, even though it was quite clear that the product was safe and efficacious. Keep in mind that regranex from chiron was approved, even though the efficacy was fair at best, along with significant recurrence, due to the fact that it was safe and there was much need in helping treat diabetic foot ulcers due to the severe morbidity and high frequency of this complication of diabetes.
b. Smith and Nephew wasn't down all that much after this news. Too many possible ways to look at this. One would be that ATIS isn't all that important for their future, or that they might just cut them loose, but this wouldn't make sense, as we know that S&N has tied up much of their future with ATIS, and even if they were to cut them loose, it should have been hit given the expectation that ATIS was going to help ATIS's future significantly, especially in their quest to become the number 1 wound care company. It is also possible that it is not really expected that dermagraft will be as severely delayed, or that S&N has some other trick up their sleeve, for either ATIS or another product with another company(nothing obvious for the market to see at this time though).
c. The IDE leaves many questions. When will it occur, and how much product can get out, with what amount of revenue? What will be the definition of unresponsive to other treatments to get the opportunity to use it to begin with? Also, if it is shown to work in patients with the IDE, or in UK/Canada, or even if the new trial shows clear efficacy, will the FDA necessarily make ATIS wait a full two years to get dermagraft out, for humanitarian reasons?
These pose some possible positive options, but there is no way to say what will happen, and this is all speculative guesswork, attempting to read between some lines and find possible ways ATIS will not do as poorly as the initial ATIS report would have us believe.
Ain't no way to predict the future. If ATIS has to wait the full 2+ years, there is likely to be a problem, as who knows what other companies, products, etc will already be out, and what tissue engineering will look like at that point. For that matter, how will the delay affect the other studies, such as dermagraft for venous stasis ulcers and cartilage for knees? Is there risk of needing to draw upon more funding, either through the 50 million credit line or a secondary?
If the dermagraft product truly works, and all indications are that it really does, and well, I can't imagine the FDA keeping it away from the public for 2+years simply because of the issue of retrospective analysis to prove who's in command, but who knows. I felt they wouldn't block it because of the efficacy to begin with, so shows what I know!
Good luck,
MLT |
