I'm trying to figure out the extent of the benefit on MSB by recent second final guidance brought by FDA.
Does MSB product satisfy the criteria of Minimal manipulation and homologous use? In my opinion, company should make clear how it is going to benefit from this guidance. Obviously, most of us including myself have assumption that it will benefit but i don't have clear indication of how? Will it be regulated solely under section 361 of the PHS Act, and regulations in 21 CFR Part 1271
or regulated as a drug, device, and/or biological product under the FD&C Act and/or section 351 of the PHS Act, and applicable regulations ?
Before jumping again on this roller coaster hoping to get thrill from new rule, lets be prudent and decide how will it increases our investment value. Lately, i have noticed management are building their theme on " opioid crisis and 21st century cure ACT. I'm still unknown in what way and to what extent it will benefit MSB.
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I'm trying to figure out the extent of the benefit on MSB by...
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