Sanofi delays BCG production to mid 2016...See this news release last week :
https://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=915
Sanofi was suppose to be back into BCG production early next year...meaning in the coming weeks. They won't before mid-2016, leaving Merck again as the only BCG producer in North America.
The BCG shortage situation will without a doubt plays a role in the FDA' decision next February. Even with a 0 % chance of BCG shortage, the benefit-risk ratio is still favorable for at least the "high risks CIS-containing diseases patients" label.
But giving that BCG production has been an ongoing problem for more than 4 or 5 years, I don't see how the FDA could reject a drug like MCNA (which appears like a safer version of BCG) knowing how fragile is (and always will be) the BCG production.
Off-label revenue could turned out to be huge for TST. In the US but also in Europe where the BCG shortage has been severe too. Smart money knows it. This could be well over 2$ can in 2 months.
M80