Biotech Values

[mskatiescarletohara]

PGS

++++Is it the FDA acting as the bottleneck, or are companies skimping on the patient numbers that they bring into these trials?

I think both apply and it depends on the pre-clinical/Phase I data package presented. The viral market is so tremendous, it's quite easy to get a viral protocol approved. Prove safety dosing in a small patient pop and move on to combo studies provided you have animal models to support MOA. Some company's can move right into repeat dosing after initial data, and some cannot because flags are raised about PK/PC values. VRTX has a good data package on healthy volunteers, and they moved directly to repeat dosing, yielded impressive log reduction, took advantage of it, tested a few combo variations to set up for Phase II and VOILA...here they are moving aggressively into a large Phase II protocol. This same type of clinical development can be noted with other various viral compounds on the market today, especially in companies focused on HIV...GILD and TRMS.

katie....