DennisDave,
I believe early on when announcing data lock they clearly indicated they'd be going to work on the BLA once their contractors had delivered the data package to them. They went into a quiet period, but if you go back to what was said before it, the BLA was their highest priority.
Many would like them to come out and say what they're doing, it's clear that they're not about to do that as long as the quiet period is in play. When the TLD and Journal comes out it's clear that the quiet period ends, then it won't surprise me to see Les being interviewed again, and L.P. speaking at investors conferences, etc. but until then the quiet period prevents it.
D.I. has done his job of not providing anything new during the quiet period, but I believe if you ask he'll verify what's been said in the past. Likewise you can find language in quarterlies that lead in this way.
Personally I believe we're quite close to submitting the entire BLA, but don't know if we're doing the rolling BLA, which still is possible. Perhaps a bigger unknown is how close we are to FlaskWork approval and whether it's actually needed for approval by one or more of the regulators. I believe that CRL and Advent should be able to meet initial demands without FlaskWork, but what I believe doesn't matter, it's what the FDA and other regulators believe that matters. There is no doubt in my mind that at some point the FlaskWork device will take over all commercial production. The question might be, will their be a few centralized places where it's made and shipped all over the world, or will they be distributed all over and be nearly as common as desktop computers to facilities that have cryogenic capability to support them.
Gary
Gary
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