Possibly one day we will hear the real story......from Dr. Morales. In closing, an interesting "Did you know" related to Dr. Morales and BCG -- BCG was initially rejected (to test) by the National Institute of Canada (see quote below). Going forward, possibly FDA-rejected MCNA will see the light of day again (if deserving) for the sake of NMIBC patients (BCG refractory). I hope someone in the press/ medical press will pick-up on this story. All the best to those in need of a NMIBC treatment and those creating treatments. And, for those that have let them down (from select FDA Adcom participants to Bioniche's / Telesta's weak bod and weak senior management ).... You know it in your heart.... You (your reputation) have to live with this forever. At least you get to live versus many in need. --- In closing, my sincere thank you to Dr. Morales for your contributions and perseverance. Two quotes related to above....Quote #1 re BCG --- CRI Impact: In the early 70s my rejection by the National Cancer Institute of Canada to test BCG on superficial bladder tumors included the reviewer comment BCG is not only ineffective and dangerous but a throw back from the stone age of tumor immunology. If I hadnt subsequently applied to and been approved for a grant from CRI, BCG might never have become the standard therapy for the treatment and prevention of early stage bladder cancer. Alvaro Morales - https://www.cancerresearch.org/cancer-immunotherapy/impacting-all-cancers/bladder-cancer. --- Quote #2 re What appeared could have been / should have been ---- Reuters, May 8, 2015...Since the introduction of BCG, almost 40 years ago for the treatment of NMIBC, Dr. Alvaro Morales, of Queens University, Kingston, Ontario, told Reuters Health by email, there has not been a new, better agent available for the treatment of these tumors. MCNA appears to fill this gap. Additional excerpts... "Progression-free survival rates ranged from 95.0% at six months to 77.7% at three years." (per Journal of Urology). The agent was well tolerated and few adverse events led to treatment discontinuation. In fact, said Dr. Morales, As opposed to BCG, MCNA does not contain viable organisms. Therefore, its safety profile is vastly superior. In conclusion, the investigators wrote, While radical cystectomy should still be considered the optimal therapy for these patients, intravesical MCNA provides a safe and effective alternative for those who are not candidates for or who refuse cystectomy. --- https://www.ccsettings.com/about/news/mycobacteria-derived-agent-acts-against-bladder-cancer/