Ok, from a stakeholder and a believer: Transparency is the following:
"""We have submitted our request for a HUD designation on our bio-scaffold device. The FDA has already agreed to the HDE pathway for this medical device. Based upon our positive meetings with FDA, we expect to receive within 30 days a positive outcome for the HUD designation. We believe that all of the criteria has been properly addressed. If, however the FDA determines that anything further is needed, we would then have subsequent opportunity to address this and re-submit after that finding. Therefore we have contingent strategy in place to address any outcome. etc, yada yada yada."""
Sentiment: Strong Buy