BCG shortage might be relevant to Telesta's valueThe supply of BCG (first-line treatment for NMIBC) has been unreliable going back to 2012. Seems like it may be a finicky drug to produce. The two main manufacturers (Sanofi Pasteur and Merck) keep having issues with manufacturing conditions and ensuring product quality. Although it's scheduled to become available again early next year, it's entirely possible that it will be in short supply again in the future.
I think BCG's chronic scarcity might be relevant to Telesta's value and to the FDA's decision. The drug has to stand on its own two feet in terms of safety and efficacy (which it does), but surely the potential scarcity of a first-line treatment supports the case that the benefits of approving MCNA outweigh the risks.
Read about it here:
https://www.ashp.org/menu/DrugShortages/CurrentShortages/bulletin.aspx?id=915
And see it listed on the FDA website here:
https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Shortages/ucm351921.htm
Also look at this article from last year that talks about how the price of Mitomycin C (another second-line for NIMBC) has increased due to the shortage of BCG:
https://www.forbes.com/sites/benjamindavies/2014/10/16/bladder-cancer-drug-shortages-and-price-gouging-the-new-reality/