PGS re: GTCB
I generally agree with your post. It's a pity that the issue of the trial size was never discussed here. I do recall a CC where they stated that, it terms of trial size, they were following a "2001 (or 2000 ?) guidance document". Perhaps that should have been the clue - clearly they were at odds with the reviewers. The opportunity to withdraw the MAA, in EMEA style, was not availaed of.
Incidentally, I hold AMRN, and it filed an MAA in 2004 for Huntingdon's, using sub-group analysis. The MAA was pulled 12 months ago; at first the stock went down, but not for long. They were already planning more trials; now they are up and running, and stock price is running too.
But in GTCB's case, all they did was just churn investor's money; we are probably 3 years away from any chance of marketing now. And the money has changed hands....
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