Over the wire today--.....'FDA Currently Considering Faster Pathway for Drugs Deemed to Offer Societal Benefit'
What is more of a "Societal Benefit" than what NVIV is potentially doing--the possibility that someone who has just had a devastating spinal cord injury could be helped seems to fit the "criteria" of a "Societal Benefit". So to the FDA "get off your duffs" and let In Vivo get on with their clinical trial already!!!
Too bad they didn't have that policy when it came to Geron's SCI trial with ESC derived OPC1's.
Even after foot dragging and extreme in-vivo requirements costing a lot of time and depleting Geron's finances they finally allow a Phase I trial to start with a dosage of 10% of what Geron felt could be effective, in a small number of patients with a large gap of time between each.
When Geron saw this happening they should have much earlier realized it would never be able to afford to get the treatment to market and should have looked for a buyer with either better political connections or maybe overseas where the FDA can't interfere.