RE:13 & 14 That's a lot of supposition Fred ; ). More than likely they are simply waiting for data on a larger or more statistically significant cohort of "optimized" patients before the release of any results. For me, the more telling/important CR data will be at 9 months...unless 9 month data are simply confirmatory & indicate a high rate of CRs post the first treatment. If there are a significant number of partial responders or those with stable disease after the first treatment, the second treatment could simply represent a successful end to a two-part solution, thus confirming we have a sound treatment protocol in place for this indication...the 9 month assessment being a good indicator of this.
The pandemic saved this company a lot of cash & a major protocol migraine in the U.S. Putting things into perspective, imagine what the potential consequences could have been if 14+ patients in the US were sub-optimally treated based on the original protocol. This could have spelled disaster in terms of the likelihood of creating extended trial timelines, an additional need for financing, & perhaps even impacting the likelihood of approval. Best of luck.