RE:Other prospectus tidbits... 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.