Re: Farmas USA
TGTX, que opinión tienes sobre este comentario que me hacen, sobre cual es el gran riesgo que puede tener TGTX, tras la info dada en el PR de ayer:
"Targeting full data presentation at a medical meeting in 1H17 and meeting with FDA in 2H17 to discuss the results and filing for accelerated approval"
The FDA could ask for a confirmatory trial without approval of the anti-CD20 glyco-engineered TGTX drug in this setting. Tentative approval is not a guarantee IMHO. Here is what TGTX said upon the study protocol PR:
"FDA agrees that Overall Response Rate (ORR) data from revised GENUINE study can be used to request pre-BLA (Biologics License Application) meeting"
http://ir.tgtherapeutics.com/releasedetail.cfm?ReleaseID=993364
alguna opinión/comentario sobre esto?
gracias