Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-161

"The key takeaway from these data were that although there had been prior randomized trials that did not show benefit, it seemed that changes had been made in the product that could have accounted for differences in activity."

The glaring hole in this is that there is no supporting proof of the company's claim that "changes in the product could account for differences in activity", or indeed if there is any improvement in clinical efficacy. At a minimum it would require a new randomized trial with the "improved" product that achieved the primary endpoint to show that the efficacy now exists. That is what the FDA has asked for and what SI is fighting tooth and nail to avoid.