Biotech Values

[iandy]

>Histology Study Results Supporting Resubmission

According to the company the safety data reported from this study was consistent with the adverse event profile established for azficel-T in previous clinical studies (mild, temporary injection site reactions). There was a single SAE of vasculitis that was reported in a 67 year old which fully resolved and was deemed “unlikely related” to treatment. The 3 and 6 month histological results for this subject were consistent with other subjects. There were no reports of abnormal fibroblast morphology, abnormal epidermal morphology, structural changes in the skin or evidence of scarring. The company also noted that at a histological level, the response to azficel-T was limited to mild to moderate localized inflammatory infiltrate that was observed less frequently at the 6-Month biopsy as compared to the 3-Month biopsy. Tissue treated with azficel-T was more likely to contain a mild to moderate degree of inflammatory cell infiltrate than placebo-treated or untreated tissue.<

http://www.gekkowire.com/?p=7950

While I believe azficel-T has a better than 60% chance of approval,I now agree with Dew that it will have limited if any commercial value.
The product had a bad reception the first go round in Europe,it's use will very likely be limited to nasolabial fold wrinkles,and I do not believe the effects are permanent.
It was overhyped when first introduced in Europe and there was a big backlash.
It is probably being overhyped this time as well.