Biomarin has participated in two new financial events in the last two days, where they shared information about financial results and gave some info regarding the drugs in development. In both of them, there was little information about BMN-111.
In summary, they informed that the BMN-111 is, as I mentioned in the this recent previous article, that they are in conversation with FDA to review the current phase 2 protocol design. It seems that FDA wants that some of the tests performed in the phase 1 study, in healthy adults, should be done also in the children participating in the next phase. It is plausible that FDA wants to see how the drug runs in children - if it has the same patterns observed in the adults. I think it is a matter of safety, which is a good perspective, after all.
A slide publicly available in Biomarin's website, from the today's conference call, informs us that the phase two is now planned to start during this last quarter of the year or in the first quarter of 2014.