Just How De-Risked Is this!Here is a more complete quote from...

Just How De-Risked Is this!

Here is a more complete quote from the FDA reviewers who okayed Illuccix (from the Risk Benefit section)!

"...
In patients with intermediate- to high-risk prostatecancer who are candidates for prostatectomy, the reference listed drug (RLD)showed low sensitivity but high specificity for Ga 68 gozetotide PET detectionof pelvic lymph node metastases. Of note, there is reason to suspect thatdiagnostic performance of the RLD was underestimated due to trial design andconduct. The RLD data also suggest that Ga 68 gozetotide PET performs better inpatients with higher grade prostate cancer in this setting.

Regardless, it is anticipated that many patients withpelvic lymph node metastases will not be detected by Ga 68 gozetotide PET.However, given similar limitations in available imaging techniques, such falsenegative results are expected to have no impact on the treatment plan ofdefinitive therapy in affected patients. The potential value of Ga 68gozetotide PET lies in the demonstration that positive predictive value (PPV)exceeds the expected prevalence of lymph node metastasis in the population ofintended use. While a positive PET scan may still need to be confirmed by othermeans, the results would allow a patient with metastasis to avoid the morbidityof surgery for more appropriate treatment. A positive PET scan might also helptarget therapy as part of the emerging paradigm of treatment of patients withlimited metastases, also referred to as oligometastatic disease.

In patients with biochemical recurrence, the RLD datashow favorable performance of Ga 68 gozetotide PET. Although traditionalevaluation of sensitivity and specificity were precluded by the diseasecondition and trial design, the PPV results demonstrate that PET positivelesions are highly likely to be prostate cancer. Additionally, Ga 68 gozetotidePET displays good detection of lesions at lower, more clinically meaningful PSAlevels. Such imaging qualities have the potential to positively impact patient carein this clinical setting where detection and localisation of disease arecritical.

In summary. The benefit of Ga 68 gozetotide PET in the indicated patient population with prostate cancer outweighs the acceptably low risks. Therefore, approval of this application is warranted.
...."


IN CONCLUSION: This will be a hard one to mess up! FDA Approval is much more certain that it is with many other biotech investments! Its just a matter of when - not if!


And, its all lining up very nicely!