Friday, August 05, 2016 10:31:25 AM
From 10Q:
"In late February 2016, the FDA accepted our proposed HDE modular shell submission and review process for the Neuro-Spinal Scaffold . The HDE modular shell is comprised of three modules, a preclinical studies module, a manufacturing module, and a clinical data module. As part of its review process, the FDA reviews modules, which are individual sections of the HDE submission, on a rolling basis. Following the submission of each module, the FDA reviews and provides feedback, typically within 90 days, allowing the applicant to receive feedback and potentially resolve any deficiencies during the review process. Upon receipt of the final module, which constitutes the complete HDE submission, the FDA will make a filing decision which may trigger the review clock for an approval decision."
With all that said the expectation of management is pushed back a bit from previous completion estimates. I think. But this is all we need to know right now.
"We are targeting completion of the study, which includes completion of enrollment, follow-up, and submission of the HDE application, in 2017."
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