Biotech Values

[DewDiligence]

>> I wasn't thinking years… it seems this [U.S.] study could be wrapped up within a year.<<

It will be a lot more than one year
before the U.S. results will be available:

6 months for FDA protocol acceptance and establishment of IRB’s
6 months for patient recruitment (GTCB’s own guidance)
12 months of patient treatment and observation
3 months for data analysis
1 month to transmit the published results to the EMEA
2 months for miscellaneous slippage
==
2.5 years

I really can’t believe the EMEA is willing to just sit on the application for 2.5 years or anything close to that.