RE:RE:Immunomedics comparison I believe the long delay was caused by some safety issues seen at one point and some back and forth between them and the FDA on data, safety and what needed to be addressed to go forward. There was a hiccup somewhere that set them back a few years.
jfm1330 wrote: [The median duration of response was 7.7 months
quote=jfm1330]I know this comparison is the absolute best case scenario for Thera, almost a fantasy. That being said, when you look at the stock price of IMMU in 2015, when they published phase I dose escalation results that I reference earlier, you see that the SP was between 2 and 3$ throughout 2015. I don' know what was the market cap, but in 2018, the SP was between 15 and 28$, it went down in 2019, and in September 2020 they were bought by Gilead at 88$ per share.
It is interesting to note that Sucituzumab Govetican (Trodely) was approved out of a phase I/II in triple negative breast cancer (TNBC) that took place between June 2013 and February 2017. It was finally approved by the FDA in April 2020 for pre-treated metastatic TNBC, and one year after, for TNBC in general. They also got FDA approval in April 2021 for urothelial cancer. I don't know why it took so long between the end of the trial in 2017 and approval. Nonetheless, they were approve in pre-treated metastatic TNBC with this efficacy data. 108 patients with metastatic TNBC were treated, these patients had on average been treated with three other chemo regimens before entering the trial. The response rate was 33.3% (partial responses + complete responses). They had three complete responses. They had stable disease for at least 6 months on 45.4% of patients. Interestingly for us, the median time to response was 2 months. The median time of response was 7.7 months. At the time of data cutoff, 87% of patients had disease progression and 71% had died.
So it gives an idea of what is needed to get an aproval. Also, five years after, they got extended approval in TNBC and only one more approval in urithelial cancer. If TH1902 can work on more cancer types, it could make it more valuable. All that without taking into account the value of the platform to generate other PDCs with better cytotoxic agent then docetaxel. So again, don't throw stones at me, I don't say Thera will be bought for 21 B$. I just try to put context at this point and to show what is needed to get there.
https://www.nejm.org/doi/10.1056/NEJMoa1814213#:~:text=IMMU%2D132%2D01%20is%20a,previous%20therapy%20for%20metastatic%20disease.
https://www.drugs.com/history/trodelvy.html
[/quote]