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Biotech / Medical : ATIS is on the move! -- Ignore unavailable to you. Want to Upgrade?

To: Paul Shield who wrote (1379)	1/31/1998 6:02:00 PM
From: Marshall Teitelbaum	Respond to of 2205

Paul, I'm not as concerned about reviews at this point, as there is one for every possible opinion. They, like these boards, are often lumping org and atis together as if they are totally competing and only one can succeed, or neither can. Obviously I disagree with this. Questions I have about ORG for the long haul, which aren't to bash, only concerns as I see them, primarily include the concern about lack of statistically significant efficacy for venous stasis ulcers less than one year old. This could yet affect how the fda will deal with the actual approval..not likely approval itself, but possibly wording on labels, conditions, etc. However, even if not, as these are minor concerns, the lack of proven efficacy will be harped on by third party payers. They look for reasons to not pay for legitimate treatments frequently....how many people are dealing with this with prescribed medicines not being covered almost daily?...ORG will need to do the postmarketing studies and prove there is a reason to use apligraf for "young" ulcers if they want the approval which counts, which is reimbursement. If they get reimbursement easily for the older ulcers, the venous stasis ulcer market would be significantly reduced, so their revenue potential would be as well. Of course, the whole industry is new and will take some time for third party payers to adjust to/accept. The postmarketing studies will be important in this process for all, whether atis, org, or anyone else, although these first two coming out may help pave the way for others to do more easily. I would expect that reimbursement will occur most easily for those which have already gone the traditional treatment routes first, and these may provide opportunities to win favor with third party payers if successful in these cases. Of course, dermagraft and apligraf are already available in other countries, and numbers regarding efficacy can be used from these, too. S&N sure made it look like they have liked what they have seen by making the big investment in ATIS, so either they have tried to manipulate(unlikely), are telling us some really positive info by reading between the lines(very possible), or have put their future in the hands of the atis pipeline(very possible, but too early to decide if positive or negative). Nevertheless, the key is showing the numbers which prove something truly is better, and eventually reimbursement will have to happen, as any lawyers out there can attest to. Remember Jerry Maguire...."show me the money!" Marshall