I'm not underestimating. With the flawed and missing data Amarex provided to the FDA for the HIV BLA it may be impossible to recompile it. With longhaulers there was enough data to submit a protocol. With BTD we needed access to the FDA and have that now. The question is will they need more supporting data that we currently don't have access too. NASH is the one that we don't have anything yet. With only 60 patients all that data can be resubmitted to the new CRO from the clinical trial sites if necessary. For monotherapy we don't know what Amarex has submitted to the FDA already in support of a new protocol, it may or may not be sufficient and that would be the most difficult to restructure given the length of the trial and the number of patients.

The saving grace for going on to phase 3 trials is that the phase 2 trials only need to show safety and possible efficacy. Much easier to prove then the standards for a marketing approval.