BLT 0.00% 2.6¢ benitec biopharma limited

peter french on abc thurs night, page-10

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    The clinical trial database is a US government site which records most of the trials in the US (non-US trials can also be registered and there are some registration exceptions). Keeping the database up-to-date has been a major problem, especially in the lack of reporting of results (the FDA has/is about to change the rules on this) and so what we read there often lags behind what is actually happening in the trial. I am not saying that UCSD has started recruiting but the fact that the clinical trials site says "Not yet recruiting" does not necessarily mean that this is the case. It could be that the database is yet to be updated.

    In terms of us hearing about the safety of the first cohort, I will reiterate that the first cohort is two patients (not one) and the Data Safety Monitoring Board has to review the data from the first patient before the rest of the cohort can be dosed. Even if the company was to make an announcement about the first patient, I am sure that they would wait until the DSMB had delivered its findings before doing so. The approval of the second patient would be all that we need to know about the safety of the first patient and maybe  this is all the company will announce.

    The DSMB will then have to review the data from the two patients in the first cohort before the first patient in second cohort can be dosed.

    We will just have to be patient.
 
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