RE:RE:Other prospectus tidbits...Great questions and I don't know. When I read that I felt that what may have transpired was that they got back all the various comments from both on the initial Type C meeting and, like you said, were looking to harmonize trial details. Looks like they moved ahead with one and are still contemplating the other. I don't know - maybe they will just look to finalize it with FDA under the assumption that they are the ones looking at things around biopsy consistency, non-invasive tests and co-morbid readings and whatever get filtered into the details would likely be fine with the EMA so they'll file it there once done as it woudl incorporate everything the EMA wants plus more. In other words the strictist view is now held by FDA slightly. Would be interesting to hear their thoughts on that though.
qwerty22 wrote: Can we assume they went through the same prolonged discussion process with the EMA as FDA in 2019/2020? My position was I believed they were engaging with both and I got that from the company ("harmonization"). Would that suggest they couldn't close the gap between the EMA and FDA, the EMA remained too far away from a Ph3 so that is why they didn't file, they expected rejection?
Wino115 wrote:
- Corp strategy is to expand commercialization of Trogarzo in new markets and its use for “…new potential niche HIV indications, if approved.”
- They filed the NDA for NASH on Nov 18th, TH1902 on Dec 6th. They are still assessing the strategy for filing with EMA for NASH and have not done so yet. They’ve hired the CRO to do the research trials in NASH.
- Studying melanoma now too.
- Initial cancer patients will evaluate max dose and preliminary anti-tumor activity.
- Use of proceeds: NASH trial $27mil, Cancer $6mil, Marketing $2.5mil, Other $1.4mil. Will be able to complete TH1902 P1 and start NASH P3.
- The Nov 2019 shelf prospectus was for $150mil of securities. They took the low end of that. May just need another $90-100 mil in 3-4 years depending on what happens with cancer development. Hopefully at a much higher price!
So they are pushing for Trogarzo to be something more in HIV and looking to expand the "indications" for it. Interesting.
Still expanding oncology to melanoma now.
Did hit the filing targets they said, except NOT for EMA filing.
Will get some anti-tumor data on the dosage trial.
Not enough capital at the moment to complete P3 NASH or other cancer trials. So eventually may need another raise. So just delayed the discussion by 2 maybe 3 years.