Replies to post #242300 on Biotech Values

[DewDiligence]

CMC problems—especially for biologics—have always been pretty common. Here’s a 2017 article on the subject from C&EN:

http://cen.acs.org/articles/95/i20/complete-response-letter-mail-one.html

Here’s a list of CMC problems posted on this board during the past five years or so (excluding RVNC, which has been discussed ad nauseam) in reverse chronological order:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168718599
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168718571
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168718516
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166931314
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165435186
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160153441
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159202177
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158851298
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=158715125
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=153900407
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150706785
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=148544386
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146192637
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=138603236
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135281410
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134958692
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134400462
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=131779250
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=130876437
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=126139243

All told, I don’t think we can say that the FDA has recently become more demanding with respect to CMC.