Who keeps kicking the can down the road with the timeline?
I suspect that it is the bureaucracy because FR seems to be chomping at the bit. You would think that the Obama administration would want to expedite something that would save enormous medical expenses over the lifetime of a patient. And this is an election year. Well, if Romney wins he was from Massachusetts. Also, the republicans seem to be better with lubricating regulatory approvals. We need this approved BEFORE November. Hello?
FDA giving go ahead for human trials and the human trials actually starting are two different things. Because of the time frame that this process needs to occur after damage, they really can't start screening until after the FDA go ahead, and that could take a few weeks before the 1st person is chosen. So FDA green light expected in Oct, 1st candidate chosen in Nov, etc etc. So saying Q1 is probably worst case and gives him wiggle room.
Yes according to the commentator human trials starting will be "early next year" which I take to mean Q1. Where she got this from is almost certainly Frank Reynolds. I agree the delay is probably due to FDA workload not allowing them to get their analysis done in a timely manner. I'll guess they don't have enough funding for enough people so I'm not sure if a Republican administartion looking to cut government spending will want to add money to the FDA and in fact may want to cut it. If timelines are changing Frank Reynolds should be up front about it and make a company PR accordingly so us shareholders are kept informed.
I agree that cutting funding would not normally help the process. But administrators in a GOP administration could potentially lubricate the process. Doing so is not always wise - under Bush, his FCC admin tried to push the failed technology, "Broadband over Power Lines" which is a dismal failure. However, in the case of the FDA and THIS technology, they need to move faster, especially for a promising med tech such as what InVivo has submitted. It helps people and it saves medical expense. Dragging it out doesn't help anybody, and is painfully indicative of the failures of our government.