Biotech Values

[iandy]

>If you’re now looking for a reason why the FDA might not approve the product, you can start with the fact that there is no medical need for another dermal filler to treat nasolabial folds.<

It's just a briefing document from FCSC but it does address the contention that laViv is just another dermal filler:

>Dermal fillers are widely employed by plastic surgeons and dermatologists to temporarily correct the appearance of nasolabial fold wrinkles and other facial rhytids. These products, containing collagen, hyaluronic acid, or other polymeric substances, achieve wrinkle correction through a space-filling effect at the site of injection. Although newer generation products have achieved a longer duration of effect and a reduced risk of hypersensitivity reactions compared to the early collagenbased fillers, the polymers within all fillers naturally degrade over time and are not replenished. Thus, wrinkle correction is temporary and re-treatment is necessary to maintain the desired appearance. In contrast, Isolagen Therapy™ provides wrinkle correction through a biological mechanism employing the patient’s own cells to modify the microstructure of the skin at the site of injection.<

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/CellularTissueandGeneTherapiesAdvisoryCommittee/UCM185519.pdf

I do not own any of this equity.
For the time being, I am just handicapping their chances of approval.
The Committee voted 11 to 3 in favor of the drug's efficacy and 6 to 8 against its safety for the proposed indication of treatment of nasolabial folds/wrinkles on the first go round.
There don't appear to be any significant safety issues.

regards
Andy