I can't see why anyone thinks the results may be 'bad'. They may not be as conclusive as desired, but I doubt they will be 'bad'.
All the evidence since the completion of the HD REACH trail last July points to the results being at least reasonable.
The announcement on conclusion of the trial said, in part:
“We have been extremely pleased with the conduct of the trial, at all levels including recruitment and Patient retention,” said Dr Ray Dorsey, Principal Investigator of the Reach2HD study and Director of the Huntington Study Group Coordination Center.
Of the 109 enrolled, 104 patients completed the trial, reflecting a retention rate of over 95%.
A Data Safety Monitoring Board met on five occasions throughout the trial and on each occasion recommended that no changes or modifications to the study protocol be made based on their review of the safety data.
The primary outcome of the trial is safety and tolerability. The trial also includes a number of secondary outcome measures from the cognitive, motor and behavioural domains affected in Huntington disease".
It is almost a given - based on the Data Safety Monitoring Board's findings - that the PRIMARY outcomes will be very positive.
As to the SECONDARY measures (the crux for future commercialisation) there is no reason to believe that we will get something positive. The animal studies were compelling in their outcomes....and I detect a change in the language used by Geoffrey Kempler between July and September 2013. In July, he said:
"assuming we achieve the positive results we are hoping for in Reach2HD, we plan to meet with the US regulator, the Food and Drug Administration,and other regulatory agencies to discuss the next steps in the clinical development of PBT2 for the treatment of Huntington disease. We plan to discuss the design of the next trial and agree on a set of clinical outcomes that, when achieved, will allow us to submit a New Drug Application for approval to start to market PBT2 for Huntington disease".
By September, he was no longer 'assuming we achieve'. He was far more positive in saying:
"Apart from the timing delay, which is disappointing, nothing has changed. The trial was conducted and completed to protocol, and WILL PROVIDE the robust data needed to meet with the FDA in 2014 as we prepare for the next PBT2 trial” (my emphasis).
And then there was the recent roadshow - unlikely immediately preceding poor outcomes....etc etc
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