Replies to post #4744 on Pluristem Therapeutics Inc (PSTI)

[n3m3sis]

I think some of your statements may have been....."MIS-SPOKEN"

The FDA has only given agreement for an in-vivo biocomparability study, nothing else.

"We are excited to have received agreement from the FDA to commence the in vivo biocomparability study," continued Yakov Kogan, PhD, MBA, Chief Executive Officer. "Following completion of the in vivo study and discussion of the submitted study results with the FDA, we expect the agency to resume the review of our pre-EUA dossier."

source

Also, CBLI has under pre-clincal development a separate compound,
which is claimed to stimulate white blood cell regeneration

CBLB612 is a proprietary compound based on a natural activator of another tissue-specific component of the innate immune system. Preclinical studies have shown that CBLB612 stimulates white blood cell regeneration. The company has licensed CBLB612 to Zhejiang Hisun Pharmaceutical Co., Ltd. for the territories of China, Taiwan, Hong Kong, and Macau, but holds rest-of-world development and commercialization rights.

source

PLX-R18 has next to no side effects at all. It also regenerates all three blood cell groups (no separate compound required).
In-Vivo study already done and results published. NHP study done.

PLX-R18

A short extract...

CONCLUSIONS



Taken together, placenta-derived stromal cells have the capacity to alleviate bone marrow failure symptoms arising from acute radiation by systemic secretion of proteins. PLX-R18 can be safely used as an off-the-shelf allogeneic treatment, enabling Pluristem to harness the power of cell therapy to provide next-generation treatment options for ARS. This new generation of therapies secretes multiple proteins with hematopoietic potential and naturally responds to the in vivo environment in real-time. The US National Institutes of Health’s NIAID is initiating dose evaluation studies of PLX-R18 in ARS as a basis for a potential pre-marketing trial in a large animal model.



To view this issue and all back issues online, please visit www.drug-dev.com
- See more at: http://drug-dev.com/Main/Back-Issues/CELL-THERAPY-PLXR18-Cell-Therapy-for-Treatment-of-1269.aspx#sthash.uGpRkOIu.dpuf

The dose evaluation is done, findings published.
Do the DD.

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