Every single day that goes by we are closer to getting this kick started. It could be tomorrow or the next day etc.. etc... etc.. March 9th is not a date that has any closure this is not a baseball schedule its a FDA schedule that is fluid.
NVIV met with FDA last year and the meeting went so well they went from having consultants and hiring out the scaffold process to moving into a start of the art facility. If a date or a checklist is needed for you to invest this is not your stock. If you want a company that has Tremendous upside and multiple options in the future with the brightest mind in the business at the steering wheel... jump on in. This is going to have a great upside with very small downside short and long term.
Why does the IDE take so long? They just re-submitted it last week. The submission in 2011 is not valid because the scaffold process is now in-house so they waited to re-submit the IDE. The IDE information is also very complicated. FDA usually gets Rats and Mice as subjects because Monkey studies are very rare and very expensive.
Why note use stem cells? Stem cells take 10-15 years to get approved by FDA this scaffold gets NVIV helping people in the short term and they can build on the product with other companies taking on the expense of Stem Cells.
When will the HUD get approved- I have a strong guess they submitted the HUD and FDA gave a reply with more questions and NVIV has replied to this and the FDA Approval can hit the NVIV fax machine any day. I would also assume they announce this HUD approval at 6am. So the selling at the end of the day makes Zero sense to me.
Dont worry about a specific date anyone that tells you a date is wrong.. FDA does not run on Dates they run on Safety and Efficacy. By the way... the African Green money Spine and the Human Spine are identical so saying FDA will not let this happen is not the odds on choice. 40 out 40 monkeys cured and we dont even need efficacy for a HDE.. just safety
The past few days it has gone down 3-4% on the last trade and bounces back to the previous number before 10am When people do DD they will realize this is not a few cents up and down when we get news its going to be 30-60% move. Look at previous HUD and IDE approvals and you will see a huge jump on this news. Many people are watching this and just want the news to jump in. I prefer to ride it up : )