Fintech 13 schreef op 8 oktober 2018 13:24:
Heb mailtje verzonden naar Acacia en reactie ontvangen die me zeer positief stemt:
The FDA inspected our manufacturer of the raw material and found some deficiencies in their processes. This is quite normal. The site was never told to stop manufacturing (if they were serious the site would have been closed down) and we are told there were no issues with any specific product. As is usual in these situations the manufacturer is required to send in a CAPA plan (Corrective and Preventive Actions) setting out what changes it has made or will make to its systems to address the deficiencies. We have been told by the manufacturer that they submitted the CAPA which they also tell us has been accepted by the FDA.
We need to speak to the FDA to understand what the process is for them to review the position at the manufacturer. From what we hear from the manufacturer everything is resolved but it may be the FDA has some other issues they feel should be resolved.
We hope this can be resolved very quickly but until we can speak to the FDA we just don’t know. We are certainly hopeful it will be within 2 months at worst and hopefully much sooner. It is a holiday in the US today (Columbus Day) so we won’t be able to speak to them until tomorrow at earliest but as soon as we have any definitive information we will update shareholders further