I would like to know what the newly submitted non-clinical data...

I would like to know what the newly submitted non-clinical data relates. FDA were specific that the drug had to be made by Benepharm. Have they changed the process? Has that change been fully validated? Has this given rise to questions around kinectics, stability or quality of drug substance or drug product. If FDA is not satisfied that the right controls are in place, this may mean a significant delay. However, if it is just dotting i’s and crossing t’s, which FDA do all the time then the delay may be minimal. Questions have to be answered with absolute clarity or FDA will keep probing. That is my experience! I’m keen to hear a full update from the company.