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Re: None

Friday, 12/20/2019 3:53:27 PM

Friday, December 20, 2019 3:53:27 PM

Post# of 54907
The fda is starting to send letters to all perinatal tissue processors that if they claim cells in their products they are going to be reclassified as a 351 product, meaning it’s a drug. Changing a product to a drug classification is a whole new set of headwinds for these companies. As long as they do not state there are cells in the product and do not make medical claims they will remain a 361. This came from one of my reps today.