Replies to post #1421 on Biotech Values

[besharp2c]

Does REGN have to file an IND prior to the U.S. Phase I study of their VEGF-Trap for the wet AMD indication? (Or have they done so already, that I haven't seen, or does the fact that the molecule has already been in other trials preclude the necessity for an IND for this application?)

Two ways to view this VEGF-Trap vis-a-vis GENR: 1) serious competition, yes, but 2) also further validation of the systemic approach.

[mskatiescarletohara]

I am very interested in REGN's VEGF trap, not just for ocular disease but oncologic indications as well. And, yes, we will see just how quickly this trial enrolls, I also believe REGN could be a potential competitive threat to GENR. Where is our Phase II enrollment? Dr. Levitt needs to get CRACKING!!!! Aventis is clearly exhibiting signs of agressiveness.

Regarding Ludwig and GENR. I didn't view that PR as a signal there was potential for problems with the MEDI collaboration. I think MEDI is having some common 'issues' with the FDA, and internal administrative obstacles to overcome; i.e. FDA requesting more preclinical data, perhaps they need further manufacturing validation on the compound, maybe a new trial design has been suggested, perhaps there has been a delay/mishap in aligning the principle investigators, schedules have moved out, clinical trial site has changed.

My first thought from the PR yesterday, was a comment Dr. Levitt made regarding Roche awhile back or was it Takaeda were looking for IL-9 components and they were waiting on the IP position to strengthen before they licensed. My supposition is this two year extension with Ludwig may be associated with pharma and GENR researching something in the early preclinical stage, in vivo/vitro synergy.


Now slap that knee! :-)

katie...