+++. But, I try to put myself in the shoes of an EMEA commissioner facing this decision regarding the world's first approval of a transgenic therapeutic protein. Around the table are some arguments pro and against immediate approval. Then information is made public that GTCB plans to do a very similar study this year to suit the FDA. Wouldn't it be understandable for this commissioner to at least ask for details on that study and perhaps take the expedient position that this decision should be postponed until the US study is completed?+++
Terrific insight, and sounds quite plausible.
I know of an analogous situation. ONCY's drug candidate is a replication-competent oncovirus - also a touchy PR situation, especially with the bad rap that gene therapy has received. They applied for an IND with both the FDA and Health Canada about three years ago. HC approved the start of PI clinicals in glioma relatively soon. The FDA said nothing for three years. When I asked the CEO about the delay with the US trial, he said that the FDA wanted to wait for definitive safety results from the HC trial before giving the go-ahead (which came a couple of weeks ago.)
So it may be that a conservative CYA approach is to wait to see what the other guys do.
What's the most optimistic timeline on the US trial, Dew?
AI
Market Data 
Markets 
