Biotech Values

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>>FDA Places Clincial Hold on Geron's GRNOPC1

[Comments?]<<


Apparently Geron has been getting *informal* input from the FDA for years about what will be required for an acceptable IND. Then a month or so ago the FDA started the process to decide on what their 'formal' expectations should be, beginning by holding a panel meeting where Geron and two other ESC companies presented and questions were raised.

I think the FDA just isn't ready, and the clinical hold is their way of punting for more time. They are probably thinking - shit ... another new technology like gene therapy that we have to regulate. If we screw up and a patient dies in the first trial, this field will be set back half a decade. We need to move slowly and be very, very careful.

That said, Geron is probably far from blameless. They've always been good at early-stage (read: laboratory) R and weak at D. They've had rat model data for the spinal cord injury for several years, but they decided not to do a pig or primate study. Why??

All the more reason it would make sense for a Big Pharma to gobble them up and sit down with the right people in the FDA to figure out how to move forward.

Could politics have played a role? Sure. But I haven't seen any clear and direct indications of that.

Find me a couple creationists on the panel and I'll quickly change my mind ...
;o)

micro