Feb. 15, 2019 /PRNewswire/ -- "We're at an inflection point when...

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lawrence1967

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16/02/19

09:38

Post #: 37456862
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Originally posted by lawrence1967: ↑

FDA update last night -

U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research February 2019

https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585414.pdf

https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585417.pdf

"The following are hypothetical examples of regenerative medicine therapies that CBER may consider for breakthrough therapy designation:

In advanced forms of age-related macular degeneration, subretinal administration of retinal pigment epithelium cells is associated with substantial improvement in either visual acuity or visual fields, or a substantial reduction in the area of geographic atrophy, at one year post-administration."

"Based on FDA’s interpretation of section 506(g), human gene therapies, including genetically modified cells, that lead to a sustained effect on cells or tissues, may meet the definition of a regenerative medicine therapy"

"We know that cell-based therapies and gene therapies may hold transformative promise for patients. This is why the FDA is so committed to encouraging and supporting safe and effective innovation in this field."

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Feb. 15, 2019 /PRNewswire/ -- "We're at an inflection point when it comes to cell and gene therapies. These treatments have the potential to address hundreds of vexing human diseases and conditions." said FDA Commissioner Scott Gottlieb, M.D

BLT Price at posting: 13.0¢ Sentiment: Buy Disclosure: Held
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