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AlpineBV_Miller

01/24/11 8:13 PM

#113063 RE: DewDiligence #113059

AMGN acquisition of BioVEX is one of those, "Wait, really?" things.

This is a replication-competent, genetically-engineered herpes virus. I have to wonder how the FDA and especially EU regulators are going to look at this. Does the company have data showing their drug won't recombine with wt HSV to create some new critter? What about the recent data suggesting GMCSF is not beneficial? Has anyone discussed the need for a REMS due to the HSV base?

Perhaps BioVex has done all their work here, but given they jumped from essentially a 50-patient Phase I/II to a big Phase III I rather doubt it.

It will be interesting to see if this bid awakens investor interest in the space. If so, ONCY might get some love.