The Company formally filed its IDE submission on 10th December 2015 after successfully completing a
lengthy pre-IDE process. The pre-IDE process involved an FDA review of the proposed Clinical
Investigational plan including the endorsement of clinical endpoints and outcomes measures.
And the announcement on 1/3/16:
The Company is also actively pursuing its Investigation Device Exemption (IDE) with the United States Food and Drug Administration (FDA). The Company filed for the IDE on 10 December 2015 and in February an additional data package of approximately 1700 pages was filed in response to FDA questions. The IDE submission process is proceeding and a face-to-face meeting with the FDA will be sought
I'm not sure which part of the announcement says the FDA is pushing back on OSL. So how did you know that FDA thinks they haven't demonstrated safety to FDA's satisfaction?
OSL Price at posting:
15.0¢ Sentiment: Hold Disclosure: Held
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