Lucent Ion 🧬

$IOVA at $2.30 is essentially valuing Amtagvi in melanoma only and assigning zero value to NSCLC. Every 10% increase in assumed POS for 2L NSCLC adds roughly $3/share. After the recent positive durability data, what do you think is a fair POS now?

Was it Prasad who intervened last minute and gave CRL last time? I thought it was Richard, director of the oncology center of excellence who had been at FDA many years at that time? My impression is that the review team initially mishandled the case by giving false hope to a weak application package, then in late stage Richard right the wrongs and gave the CRL that it deserved. You are not oncology wonk, how do you know if the trial is designed per industry standard? Do you know that they enrolled many patients who still have multiple approved credible options left? Do you know the response rates are highly variable among these different patients populations with different lines of prior treatment ranging from as low as 12.5% to 26% to 33% and all the way to 40%? This is from their own publications. And yet the management still claims consistent efficacy among subgroups. Can you name one precedent where accelerated approval was granted in the BRAF mutant advanced melanoma population who didn’t receive prior BRAF/MEK inhibitors which can produce response rate as high as 50%-70%? Last time i checked, all the accelerated approval data packages in advanced melanoma in recent history required prior BRAF/MEK inhibitors exposure for BRAF mutant patients, this was the case for pembro, nivo, and lifulecel. BRAF/MEK unexposed BRAF mutant patients are easier to treat and indeed is the population that’s driving the ORR in RP1’s study. Therefore, imo, the last CRL’s criticisms are all spot on: basically they ran the trial in a highly heterogeneous population(including population that aren’t suitable for the single-arm accelerated approval path) and saw heterogeneous response rates all over the place among those subpopulations …. As a result, it’s just not conclusive. Idk, maybe FDA will approve it this time with all the pressures from different sources. But the data is the data, and it’s just not there. I hope they can design trial properly and show it’s truly more efficacious than SOC and benefit patients in future perhaps with their phase 3.

$CYTK not much vol but pcr .33