Staggered enrollment is good for preliminary results news on scaffold trials within 90 days of each patient enrollment. This way there will be a constant newstream throughout the year on how each single trial is progressing. News that there were no harmful complications of surgery in and of itself will be positive as the trial is designed only for safety and not efficacy (no stem cells to be used at first as far as I can tell). Furthermore, ANY notable improvement - bladder function, sensation or wiggling of toes, etc. - will be groundbreaking news because the expectation is that all patients who are fully paralyzed before surgery will remain fully paralyzed for life.
The submission to FDA of each single trial preliminary result will in and of itself be considered material news and will have to be reported in an 8K.
What that means is that by end of 1Q 2014 NVIV will have preliminary results released on the first ever scaffold implant testing in a human being, which is groundbreaking news. Only about one quarter behind the original preliminary results timeline.
The difference of course is that trials will take longer. But the upside to that is there will be a constant stream of preliminary news every 3 to 5 months as the trials progress, material news which is great for the market sentiment.
In the final analysis, Jason Napodano thinks that product commercialization will probably be about 5-6 years out, using this approach. However, the benefits are that the approach can be adjusted along the way based on what is learned from each patient, and the results will provide the market with good tracking information and hopefully lots of positive news on the safety to support positive sentiment with a stream of news releases.
Keeping a balanced perspective, what biotech product DOESN'T require a 5 year period until commercialization? ONVO, one of the most revolutionary biotech product developers, on a par with NVIV for revolutionary technology, is among the highest sentiment biotech stocks of all right now, and it is well understood by all investors that their product is AT LEAST 10 YEARS to commercialization, with great uncertainties. It is the promise of the technology for market dominance and tremendous value to meeting an unmet need that makes NVIV as well as ONVO great stocks to invest in at this time.
