Hi Dalts
Yes i understand all that dalts
But under a regulatory approval you cannot just stamp a Ph3 trial set up into a ph 2b
That is why i am taking it they said in the Ann there will be no more initiations of the ph3 set up
They will have to back pedal somehow
I am tipping that the trial starting last 1/4 will be the ozz one we have boys set to go here i would have thought,
European countries could be a whole different
Scenario, look at the early access programme for instance after all the setting up fell over just because the drug was manufactured by a different company, so rendered useless and that put paid to the EAP
hoping they have learnt by that, but do you understand where i am coming from outside our jurisdiction could lead to delays and again it took us 19 months ok ast time for a 6 month trial ad you say we thrn have the following half of the trial and the follow up to add onto this
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