$NVIV Fast track will derail short thesis: Already got device approval, have green light to start trials.
NVIV is not your garden variety biotech drug approval cycle, with the interminable delays and fears from NDA to PFUDA. In most biotechs, these are treated like make-or-break moments. In the case of NVIV, clinical trials have the green light to begin, since they already have their device approved (HUD and IDE granted).
Furthermore, the outcome of those trials won't be judged by the harsh criteria of drug treatments, given their device exemption status. All that has to be shown is that the biopolymer scaffold does no further harm to patients with spinal cord injury undergoing treatment and some limited measures of success, not held to the same high standards of statistical significance that are embedded in the regulatory mechanisms for drug approval.
Hence, since they have already proven in multiple animal studies that monkeys were not harmed and that the device could be successfully implanted by a trained surgeon, and have shown 5 or 6 measures of improvement on scores of lower extremity function, it will not be difficult to show the same in the initial human trials.
Biotech shorters, beware: This company is not in the same risk category of the drug approval pathway. While risk/reward pre-clinical trials would normally favor a short over long in the near-term by a factor of 3 to 5, in this case there is zero risk clinical trials won't start, and very, very low risk of any demonstrated further harm to human patients being treated for acute spinal injury given the 3 series of successful tests conducted in primates. NVIV's path to success has been shortened by 3 binary risk events compared to a drug development story, and shortseller's risk reward here is NOT the same as with a biotech drug approval stock.
AI
