Biotech Values

[shareholder_boar]

Re: RVNC /FDA ODD in cervical dystonia

Isn't it more the case here that the RVNC molecule is not the same as the other approved botulism toxins that allows it to gain ODD? Only for drugs that are "otherwise the same" must the sponsor state why it may be superior.

https://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=238362420de6b80c19b2a9c44b73a843&rgn=div6&view=text&node=21:5.0.1.1.6.3&idno=21


In any event, daxibotulinumtoxinA is now the fifth botulism toxin granted ODD for cervical dystonia (along with baclofen).