Rajendra,
Actually, I disagree, except for the part about licking wounds unfortunately. ATIS had stated all along that the FDA was still with concerns about the issue of retrospective analsysis, and obviously they weren't able to get past it, even though the "expert" advisory panel was. I still can't figure how regranex could get approved and dermagraft couldn't, but the key was this retrospective analysis issue. The manufacturing issue wasn't all that big an issue or unusual truly, as it turns out. This happens with companies frequently, and if all is fixed, ie passes the 8/98 inspection, then this concern is only history.
Barry...hope you're having fun in France....to answer your question about the IDE...actually, even if there were to be a lot used, there wouldn't be sales from it, as I have learned that ATIS could only get cost for dermagraft with an IDE. The only positive of this route is that they would get their name/product out, get people comfortable with the product, get people familiarized with its use, etc., and ultimately help lessen the time it would take to penetrate the market later, assuming there is a later, and that they're not way too late to the actual market. Meanwhile, they're out in the England, Canada, Ireland, Norway, and Finland, and could still get out in some other countries, but still await getting to be part of the national healthcare budgets.
The main short-term issues are passing the 8/98 inspection and workig out the details with the FDA of the protocol for the next dermagraft study. This second one is key, as the market would respond much differently to a shorter, smaller study than to a longer, larger one....ie 1 year vs. 2 year, etc. Even though the venous stasis ulcer study is to start later this year, it is unlikely dermagraft would get to the US market for this before 2000, so all needs to get rolling. The cartilage study is still pending, while the company is optimizing the product to avoid the retrospective analysis issue that dermagraft ultimately got clobbered for.
Ultimately time will tell. We can all hope that dermagraft gets approval before the study is actually completed, but that is all it would be. For those who still hold, this is now a longer-term and more speculative investment than before, although there is potential. Nevertheless, it is a new ballgame.
Good luck all,
Marshall |
