RE:RE:RE:CG Oncology IPO TodayCG shows what a slick operation from day 1 can achieve.
- Massive number of recruitment sites
- Big venture capital from day one with multiple rounds of cash raises
For the drug by itself they have data up to 9months only. They report that they won't be reporting full data till end of 2024. If they apply for FDA approval they will likely have to wait around 9 m since it is a biologic agent. So thier data doesn't count as competition in any FDA application till mid 2025.
It is depressing that they are so slick and have so much money so easily. Wish TLT had those skills. Not depressing in terms of outcomes as 9 m of data only so far for the single agent.
I would note that immunity bio had the same challenges. They had poor data on the drug by itself but better when combined with BCG. However, from the last that I can see they have the issue of losing CR's over time. When they had their FDA application rejected in 2023 it was due manufacturing concerns (huge issue that comes up with biologic applications) and they were asked for more long term follow up data. The latter issue makes me hope that the FDA is wanting more data on what happens when stop the constant instillations.
For BTD application, TLT only needs to reference existing options so they still beat all existing options. I hope that somehow the very disappointing data on Adstiladrin (once you get past a year the CR's fall off quite quickly) will make the FDA require more data on what happens when you stop the intensive instillations. Ruvidar is the only drug that I know that has data showing these results 9 m after any treatment given.
Still a bit frustrating that TLT has such good science and cannot raise much cash over and over again.