(Total Views: 611)
Posted On: 11/03/2023 5:28:19 PM
Post# of 155050
Shareholder letter and FAQ's are great. Much better than the old CC's. Some highlights:
Clinical Hold - The Company recently provided additional information to the FDA that we believe answers the FDA’s remaining questions. We hope this submission will lead to the removal of the clinical hold. The Company is on standby to address any other issues that may be noted by the FDA, and is optimistic that the time, effort and significant cost investment over the past year will result in the removal of the hold.
CEO - Currently, the search has been narrowed to several highly qualified candidates, and we anticipate having a new CEO in place by the end of the year.
Amarex - The final arbitration hearing is set to commence August 12, 2024. We would then expect the arbitrator to issue their final order sometime in the weeks following the conclusion of the final hearing, perhaps in late September 2024.
Clinical Hold - The Company recently provided additional information to the FDA that we believe answers the FDA’s remaining questions. We hope this submission will lead to the removal of the clinical hold. The Company is on standby to address any other issues that may be noted by the FDA, and is optimistic that the time, effort and significant cost investment over the past year will result in the removal of the hold.
CEO - Currently, the search has been narrowed to several highly qualified candidates, and we anticipate having a new CEO in place by the end of the year.
Amarex - The final arbitration hearing is set to commence August 12, 2024. We would then expect the arbitrator to issue their final order sometime in the weeks following the conclusion of the final hearing, perhaps in late September 2024.
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