I really think that the 120 patients in PDD in Spain have been dosed , the trial in Spain is finished and just waiting for patients in Au.
From polarbear77:
Rett Syndrome Association of Australia: "Part B of the adult study that will take place at The Alfred in Melbourne will commence in first week in October. "
So Avatar study has part A and B, like Rett in Usa and then probably Pediatric study as well.
Part A at least 6 patients in every study , probably a few more patients because both trials have more patients.
So I would say another 12- 30 patients.
Until now we had the same number of patients in Pdd and Rett, = 120, obviously its not a casualty.
So I suspect that the number of patients Part A Avatar + Part A Pediatric = number of patients In Au in Pdd,
I think that both trials will have the same number of patients, I would say... 140-150..
I think is not inusual to enroll more patients than originally planned, for example NTRP enrolled 8 more patients...LOL !!
In PDD in Spain between the announcement of 50% enrollment and 70%,( new sites we added in Au a week earlier of 70% announcement) during those two months there was a surprising slow progression, but I think that is not correct , the progression was good , because this 70% included the new 20- 30 patients in Au, so 70% of 140-150 patients , not 70% of 120 patients, so with this progression considering 140-150 patients the patient 120 in Spain was enrolled during May/ June .
My thoughts are based in Dr Freire words, obviously just speculation..
How long is this second phase planned?
"The follow-up period of the patients is 14 weeks, there are 2 previous weeks called the screening period to see if the patients meet the necessary characteristics to be in the study and the total follow-up is 14 weeks.
And we believe that the OBJECTIVE IS FOR MAY APPROXIMATELY, all the patients necessary to carry out the study are already recruited. "
So Avxl will have blinded data from first 120 patients soon, so like is the same trial In Spain and Au I guess that we have to wait until the trial is finished in Au... Just asking?
Saludos!
