RE:Sanofi delays BCG production to mid 2016...There is something seriously wrong with production of BCG with both manufacturers. Having production problems with two separate manufacturers at the same time approx? REALLY? Something wrong with the strain they have to use? Mutating somehow? Probably the reason we got to submit BLA for free on a small trial and are being pushed along by FDA. MCNA is virtually the same as BCG without the toxicity and difficulty of administering. Same Dr discovered both drugs. FDA doesn't want their azz hanging in the breeze when we have massive shortages ( or is this happening now? ). Maybe this is the reason TST talking about studying Belleville plant and having additional MCNA production there, as stated in one of their last presentations.
There is nothing else even close to being ready to alleviate coming future shortages.
Cheers
13PD