Replies to post #224317 on Biotech Values

[ghmm]

FCSC:

I don't follow the company too closely but did listen to the call. I don't have a positive sense for the company. As far as the PR/call adding to my sense of mistrust for the company is their mention of submitting CMC information prior to starting the study. I am guessing their mfg is not up-to-par for COMMERCIAL use and so by FDA gene therapy standards what they are calling a Phase 3 study (which is fine) would not be enough for registration.

https://seekingalpha.com/article/4251297-fibrocell-science-inc-fcsc-ceo-john-maslowski-q4-2018-results-earnings-call-transcript?part=single

Disclosure long ABEO which also has an RDEB program and is spending quite some time to get an in-house commercial manufacturing facility ready (tech transfer from Standford product) for their Phase 3 program