RE:RE:RE:AGMWell if it`s a complete given that`s fine but not being party to the conversation between them have been of the belief that nothing is set in stone and that both the FDA`s requirements and the Company`s decisions may vary in response to the developing outcomes of the Trial itself.
Had thought it for for the Company to judge the timing of its`BTD submission.They`ve probably only got one shot at this and given that the first 12 of Phase II were radically under-treated and with the likely benefit of a greatly clearer picture of the consequences either they the FDA or both might now think it better to wait so that a higher proportion of twice-optimally treated patients can skew the sample to a better Clinical advantage.
If the Company has no choice but to go with the first 25 at 450 days` (or maybe the first 22 plus the 3 from Phase IB?) then so be it. In that case thank goodness for the slow initial recruitment or we could have had at least 22 radically-undertreated enrolees as the basis of our BTD submission.