Thanks ajbhu,
So it seems the ema are happy with the device. BUT they have taken one component as the medicine and now require the medicine regulatory pathway.
Looks like could be done in parallel with FDA in the U.S.
I think it's going to be a long frustrating wait.
Was tis aware of this issue always or were they blind as we were?
If the EMA said 1 year ago "by the way you do realize you won't get approval unless you have studies on this one component so you better not apply right now" and tis replied " I think we can get it" and ignored the advice? I can't inagine this but who knows.
So my thoughts questions and answers definitely to get some closure for the rejection.
But moving forward is the timeline to get the medicinal studies complete for both. 2years? Or they they be fast tracked?
Either way a long wait and if the product is that good I'll probably stay in.
Happy to support the group with a significant amount of shares being held.....
TIS Price at posting:
11.5¢ Sentiment: Buy Disclosure: Held
