Ann: Trading Halt, page-93

To remind you- and all other handwringers:

From the recent Quarterly:

" The Company successfully completed a mid-cycle review of the product in 2Q CY2023. The midcycle communication indicated no significant issues had been identified by FDA as a result of its review of product quality, non-clinical or clinical and that there were no major clinical safety issues, no risk management or advisory board requirements. "

Flat out rejections are usually preceded with requests for more data, more detailed submissions and the like.

I reckon you don't go from 'no issues' to flat out rejection without an inkling from the FDA that they were troubled by something. The process is a lot more rigorous than that.

The only information the FDA had been asking was around the more mundane labelling aspect.

The CEO has personally launched more than 15 products previously, he knows precisely how to skin this cat.

Finally, my wife would tell you I am right precisely less than half of the time...Cheers