Ps …Krause was there before the last CRL……she favours garnered then….not expecting any this time around either…..just really hope that they have learnt something from two previous failures…and they have received ‘collegiate advice’ from the FDA and they have acted on it in a timely manner. We won’t know until the yellow orb appears….as LTH we have every reason to believe there are no easy decisions from this regulatory machine.
Ps …Krause was there before the last CRL……she favours garnered...
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