Replies to post #121291 on Biotech Values

[TaxiCaT]

Wow - solid argument: Here is mine -

I’ve already presented an argument for why laViv won’t garner commercial sales of any consequence.

I could care less about the commercial sales, i'm playing the bump on approval - although I don't agree with you here.



As far as my reasons why I feel they will recieve approval, the company had a SPA, Advisory Panel Meeting, CRL, & safety study designed by the FDA which FCSC was proactive with. Study met all safety endpoints. FDA approved them on efficacy but denied them with a close vote on safety during their first submission -

Also we have this individual on our side:

Jeanne Novak, Ph.D.
Acting Vice President, Clinical/Regulatory Operations

Dr. Novak is a Founder and Principal of CBR International, a scientifically-based biotech development company. She got her Ph.D. in Experimental Pathology (Cell Biology) from University of Utal Medical School, and served as a FDA Senior scientist, credentialed Inspector and expert advisor to FDA Center Directors. Dr. Novak also serves as Acting Senior Vice President to biotech companies and she is pivotal in several recent FDA approvals. Currently, she is serving as the Authorized U.S. Regulatory Representative for Fibrocell.

here is no medical need for another dermal filler to treat nasolabial folds

Why does this matter and who are you to decide that? FCSC just missed approval last time around -

[JustGoLong]

Is that a valid reason not to approve a drug?

[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