Wednesday, June 13, 2018 2:55:28 PM
Thank you for the article. It provides an interesting perspective on bringing cell and gene therapies to market.
I agree that changing the status quo can take a long time. It also presents unique challenges and uncertainties. It is encouraging that both the EMA and FDA have recognised the need to adapt their processes to new therapeutic technologies. This new evolving regulatory environment seems to strongly favour therapies like Pluristem's and I think they are in a good place. The example (withdrawal) of Glybera is an extraordinary and extreme one, but I cannot envisage a situation like that for Pluristem.
HappyBee
PS Thank you, Allo, for confirming my thoughts regarding conditional marketing approval (I'm glad that my cognitive function seems to have been somewhat restored :)). That really would be "Beyond HUGE! "
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