Avid Bioservices Inc (CDMO)

[Big On Tarvy]

Katie, my assumption has been the Company would complete a Ph 1b combo trial with Ribavirin before they decided on the Ph II protocol, although I did not make that clear in my July 22 post.

You may well be right that delays in starting the Ph 1b Bavi + Riba combo study are related to wanting to know more results from the current repeat dose trial. Ideally, one would determine from the current repeat dose trial whether the 1mg/kg or 2 mg/kg dose level produces the best results over a 12 week period before fixing the protocol for the Bavi + Riba combo study.

I have no recent information on this issue but I will speculate as follows: The Company said it would complete "enrollment” in the combo study before year end. If you use the current repeat dose study to determine the correct dose amount, then enrollment in the combo trial should go faster (and still be finished by year end) because they are not doing dose escalation.

Also, it makes sense to have completed the dose escalation analysis before starting the combo trial so that the combo trial can be used to isolate a comparison of (a) 18 patients given repeat doses of combo therapy, e.g. Riba + Bavi at 1 mg/kg per dose with (b) six patients treated during the current trial with repeat doses of mono theraby, e.g. Bavi at 1 mg/kg per dose.