RE:RE:An optimist's view
I would like to add a much more improved and frequent communication with the capital market as all those milestones if achieved can boost the value of the company fairly well. If that part doesn’t get fixed rest assure the rest of THTX’s prospects won’t get the recognition it deserves.
If the potential partner is convinced that the science has potentials I don’t think either them or THTX would like to postpone the trial for NASH any longer than necessary.
They don’t need the sBLA for F8 to start the trial!
From the CC:
“And for now, we are going to actually file with our FA formulation as soon as we have completed the human factor study, but at the same time if we were to find a partner now we could actually start to see on the trial a [indiscernible], right?
Christian Marsolais
Absolutely. Then we – in terms of the trial, we already have identified a CRO that can work with us, and as soon as we make the announcement shortly thereafter a few months, six months thereafter we can start a trial.”
My email to Leah July 2020:
“As per the PR today the company will be filing for sBLA with FDA in early 2022, can you kindly advise without FDA approval of the sBLA can company use F8 for proposed clinical trial for patients with HIV and NASH.”
Her response:
“Thank you for your email. Interestingly, we are able to use the F8 formulation in the study before receiving sBLA approval.
Hope that answers your question.
Leah”
I also spoke to the CFO around same time as per his comments they were confident to get the sBLA.
It sounds like sBLA isn’t an issue so if they get the suitable partner they should get on with it and it seems like that is their plan as well.