FDA is a hypocrite and rot to the core if CHF don't get at least...

FDA is a hypocrite and rot to the core if CHF don't get at least Accelerated Approval. Let's me explain:

FDA has just approved Novartis Pluvicto, a Lutetium radiotherapy for metastatic castration resistant prostate cancer based on a Single phase 3 trial.
"Efficacy was evaluated in VISION (NCT03511664), a randomized (2:1), multicenter, open-label trial that evaluated Pluvicto plus best standard of care (BSoC) (n=551) or BSoC alone (n=280) in men with progressive, PSMA-positive mCRPC. All patients received a GnRH analog or had prior bilateral orchiectomy. Patients were required to have received at least one AR pathway inhibitor, and 1 or 2 prior taxane-based chemotherapy regimens. Patients received Pluvicto 7.4 GBq (200 mCi) every 6 weeks for up to a total of 6 doses plus BSoC or BSoC alone. The trial demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS). Hazard ratio (HR) for OS was 0.62 (95% CI: 0.52, 0.74; p<0.001) for the comparison of Pluvicto plus BSoC versus BSoC. Median OS was 15.3 months (95% CI: 14.2, 16.9) in the Pluvicto plus BSoC arm and 11.3 months (95% CI: 9.8, 13.5) in the BSoC arm, respectively. Interpretation of the magnitude of the rPFS effect was limited due to a high degree of censoring from early drop out in the control arm."
Okay, so the primary endpoint was achieved, although the Median OS was 15.3 vs 11.3 months, meaning patients were given 4 extra months to live. But I don't have a problem with that. Novartis can game the system all they like, I don't care.

BUT, HOW IS IT OK for FDA to approve this drug IF THE PHASE 2 it showed 7.4 GBg performed WORST than 6 GBg? and NO CONTROL ARM? I thought FDA will consider clinical data from ALL trials (Said FDA to GVHD?). So the FDA is okay with suboptimal dose of 7.4 GBg, and a Single Phase 3 trial with a 95% treatment-emergent adverse event (TEAEs)? WTFFF????


So, the primary endpoint of TEAEs is 95%, meaning almost 100% of patients will have adverse events, thus it's OK to NOT include a CONTROL group. So, there is nothing to compare to? WTFF is this phase 2 for? Even better, they TERMINATE the study, because the result is so SH$T. WOW... hats off!

If you look at the secondary endpoint, a PSA reduction of >50% is considered positive. Clearly 7.4 GBg is the wrong dosage in the Phase 3 trial despite hitting the primary endpoint. Why would the FDA "Approve" and not ask Novartis to go back and do a trial with the optimal dose? At what dosage has the FDA just approved? What dosage should clinicians use in practice?????