Pluristem Therapeutics Inc (PSTI)

[Spideyboy]

Strictly speaking thesaud's post just says that they got through to market approval on animal rule. This doesn't specifically out line if they did or didn't have to provide any safety data that could have come from another indication that Neupogen was tested for, for example its main indication Neutropenia.

This said however, Neupogen was also tested on NHP with regards usefulness in ARS, which shows nice overlap with R18.
https://www.ncbi.nlm.nih.gov/pubmed/26425903

Also something from the FDA website on the animal rule:

[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2016]

Sec. 314.610 Approval based on evidence of effectiveness from studies in animals

Approval under this subpart will be subject to three requirements:

(1) Postmarketing studies. The applicant must conduct postmarketing studies, such as field studies, to verify and describe the drug's clinical benefit and to assess its safety when used as indicated when such studies are feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When such studies are feasible, the applicant must conduct such studies with due diligence. Applicants must include as part of their application a plan or approach to postmarketing study commitments in the event such studies become ethical and feasible.

(2) Approval with restrictions to ensure safe use. If FDA concludes that a drug product shown to be effective under this subpart can be safely used only if distribution or use is restricted, FDA will require such postmarketing restrictions as are needed to ensure safe use of the drug product, commensurate with the specific safety concerns presented by the drug product

So as well as what here appears to be saying about safety in humans being able to be done based on the Postmarketing studies, and that this approval will be fine with potential restrictions in distribution for ensuring safe use. Given the US gov will be deciding if/when to use it, I think we fill that criteria too.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314&showFR=1&subpartNode=21:5.0.1.1.4.9