NZ,
Many factors to keep in mind, such as which uses and indications for particular products. My guess is that anyone who breaks into this industry and stays solely with skin products ultimately will have problems, as there will be increasing competition, but a really good product which gains acceptance in the medical industry(drs. and managed care approval) may be hard to displace on a widescale in the intermediate term. Nevertheless, being a tissue engineering company means being aware that skin is only the beginning. It appears that the next area involves products such as cartilage...what I like about ATIS is that they are also picking products with relatively good potential(from a market perspective), although TC obviously wasn't/isn't for this purpose.
Haven't read the info on ORG, but there are some reasons to be suspicious still. However, I don't think companies with a product on expedited review going to panel have typically been rejected with any regularity. It is very unlikely that dermagraft will get denied, but the question after becomes where it goes....later revenues and later product production, etc. ORG still has to potentially deal with the question of frozen or not, as I'm not sure if this may affect their FDA process. I doubt very much that making the FDA mad, as someone else had earlier implied secondary to the mention by atis of having been on the panel, will be an issue for whether ATIS gets recommended or not....the panel is actually composed of non-employees of the fda, and if a product really looks good, they will not hold it back imo.
Anyway, enough serious stuff...have a great holiday.
Marshall |
