Replies to post #209887 on Biotech Values

[DewDiligence]

Re: RVNC /RT002 formulation (purity)

Do you have any specific citation referencing and delineating the differences in purity between RT002 and Botox?

There are no published comparisons that I know of because RVNC's formulation is a trade secret; however, page 1 of RVNC's 10-K confirms the assertion about purity in the post you're replying to:

https://www.sec.gov/Archives/edgar/data/1479290/000147929017000013/rvnc1231201610k.htm

Neither formulation of our product candidates [i.e. RT002 or RT001] contains albumin or any other animal or human-derived materials.

CEO, Dan Browne has further asserted that RT002’s formulation consists of only the active ingredient (a purified strain of type-A botulinum toxin) and a proprietary peptide.

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Botox's formulation is described in the FDA label (http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103000s5252lbl.pdf ):

BOTOX (onabotulinumtoxinA) for injection is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A, and intended for intramuscular, intradetrusor and intradermal use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins [emphasis added]. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying.

…Each vial of BOTOX contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.