Hi Iken2950,The best summary of the program can be found in the...

Hi Iken2950,

The best summary of the program can be found in the last presentation, from approx. 27:40 mark (see presentation below).

Here is a screenshot of the trial design:




I kinda assume the fact that an IND has been submitted and successfully approved it infers that the two stages both fall under the Phase 3 banner, this is just my own thoughts though, happy to be corrected.

The above adaptive trial design does infer that the Dosing study will be kicked off first and then based on the Interim Analysis the dose will then be selected and used in Stage 2 as Donna mentions. This dose will also be the one adopted for 003 (Confirmatory) study and no doubt any subsequent studies (eg 010 and the durational/extension studies as an example).

I believe the total number of centres is around 65? Each major jurisdiction will have its own Principle Investigator...eg
USA
EUROPE
UK
AUSTRALIA

I believe the approximate timeframes Donna has mentioned incorporates the above design and protocols. As she stated there is some conservatism added in. However, its prob best we go with these and see how it pans out, these things are somewhat notorious for taking longer as we have often seen in the past. Better to UPOD!


As per usual, best to DYOR