Ann: PTX successful immunogenicity testing of OmniCAR, page-90

Certainly, the FDA accepts in silico data, but still only in support of traditional animal preclinical data.

While the FDA has expressed interest in in silico testing for drug research, as of 2020, there are no guidances that allow in silico tests to replace preclinical animal testing in drug development, although in silico data can certainly be submitted in support of animal findings, and may reduce the number of animal experiments that are required.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7185927/

Therefore, although the in silico tests were successful, and it’s great that PTX has harnessed advanced ICT, preclinical animal testing still needs to be completed before PTX can start clinical trials, as indicated during the webinar.

I didn’t want anyone gaining the false impression that, with in silico testing successfully completed, human trials could start soon when the company guidance is that the first human trial is still two years away.