The company expecting to get an approval using the data they've already collected from the trial studies. Company stated they have sufficient data for a FDA approval upon resubmitting the data. I believe the FDA will approve their resubmitting paperwork of the clinical trial study. The study missed the end cap by a micro fracture of 2 of 247. I will hold my shares until the approval.
The guideline change while Histogenics Corp were conducting their clinical trial studies. It was stated in the conference today.
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