I find the broker reports a little optimistic in view of the FDA reports to ODAC.
The latest one appears even more scathing of CXS's methodology... particularly the vial volume in point #5. To grant approval would be a green light to others being scientifically and statistically sloppy. Also, the "no other treatment" argument doesn't hold a lot of water if there isn't a sufficiently high confidence in omapro efficacy from data provided.
I would be surprised to see ODAC appear to condone the methodology by granting approval. It would seem more appropriate to delay approval pending supplementary data.
I guess we'll all know about it tomorrow (or tonight for the keen ones)!
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