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flipper44

09/09/19 4:37 PM

#243392 RE: Jack2479 #243386

Thanks Jack. I missed that very important detail in Cognate's PR.

Since 2002, Cognate has serviced autologous and allogeneic products in various stages of development from preclinical to Phase 3, and most recently in pivotal Phase 3 with FDA pre-approval inspection preparation.



https://www.globenewswire.com/news-release/2019/08/07/1898347/0/en/Caladrius-Biosciences-and-Cognate-BioServices-Establish-Manufacturing-Agreement-for-Phase-3-Confirmatory-Pivotal-Clinical-Trial-of-CLBS14-in-No-option-Refractory-Disabling-Angina.html
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colmar

09/09/19 4:43 PM

#243397 RE: Jack2479 #243386

Nice. Good one, thx.
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Hbpainter

09/09/19 5:39 PM

#243404 RE: Jack2479 #243386

Excellent find. We are getting close.
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Hansm7777

09/09/19 6:58 PM

#243410 RE: Jack2479 #243386

Getting exciting now...
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iclight

09/10/19 5:24 AM

#243453 RE: Jack2479 #243386

That usually happens when a trial approaches its primary endpoint trigger. So 3 years ago for this company. Or maybe when it submits a BLA. So never for this company.
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eagle8

09/10/19 6:50 AM

#243456 RE: Jack2479 #243386


Thank you Jack.

Great D.D.

GLTU
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Evaluate

09/10/19 1:23 PM

#243522 RE: Jack2479 #243386

Also re Cognate ... was this previously posted? Cognate BioServices Secures Growth Capital Investment from EW Healthcare to Continue to Expand Commercial Manufacturing Capacity and Services for the Cellular Therapies Industry
BALTIMORE and MEMPHIS, Tenn., Aug. 26, 2019 /PRNewswire/ --
Cognate BioServices, a leading contract development and manufacturing organization ("CDMO") in the global cellular therapies industry, announced today it has secured a financial sponsor to support its short-term and long-term growth as it closed on a round of growth capital from EW Healthcare Partners ("EW Healthcare").

"We have known Cognate and followed its progress for a while and have been very impressed with the way in which the management team of Cognate has developed the business. Looking toward the future, the Company's strategic plans are quite compelling and well aligned with our long term vision for the Company. We look forward to supporting the Cognate team as it continues to execute on its vision," commented Evis Hursever, Managing Director of EW Healthcare.

Cognate is one of the only CDMOs capable of handling the volume of personalized products being approved by regulators today. The Company has commercial scale manufacturing capacity in Memphis, Tennessee to support products for both the E.U. and the U.S, and is continuing to expand its footprint to meet the needs of its clients and the market. The transaction includes significant growth capital to support Cognate's commercial expansion that started in 2015.

"Cognate is delighted to be partnering with EW and its team to continue to expand our capacity and capabilities," according to J. Kelly Ganjei, CEO of Cognate BioServices, Inc. "With EW as a new partner, in combination with our existing shareholders, we can remain focused on aggressive growth to meet the needs of the growing commercial markets in cellular therapies. We have a number of exciting service offerings and capabilities that we expect to be able to provide in the near future that will directly translate to the benefit of our clients and their patients."

The capital raise and partnership with EW will further support Cognate's commercial manufacturing infrastructure and scale up activities for its clients and prospects. This partnership with EW further secures the Company's future as a leading CDMO in the commercialization of advanced cellular therapies such as car-T, NK cell, TIL, MIL and other cellular immunotherapy products.

https://www.ptcommunity.com/wire/cognate-bioservices-secures-growth-capital-investment-ew-healthcare-continue-expand-commercial