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Re: Umibe5690 post# 71265

Friday, 08/26/2016 12:27:39 AM

Friday, August 26, 2016 12:27:39 AM

Post# of 692852
thank you umibe...."the manufacturing of the vaccine is the product"....my humble take on this is as follows....(maybe said better elsewhere by smarter people, but here goes me)....If one million vaccines are produced for one million patients, each one will be DIFFERENT because each is personalized for each patient....no question about that....here is my "rub"....the FDA wonders how to approve a product that is different each and every time it is manufactured and tell the general public it is safe for everyone....what about the million + one??? it will be different, no one knows by how much or just whatever....it might not work on this person's cancer the same way or for the same amount of time.....every personalized manufactured vaccine is unique and different....FDA does not know how to approve such a treatment, yet.... so, the enrollment is put on hold, the trial is elongated, the patients checked and re-checked....JMHO...I honestly doubt Linda will bring out "new" news in Berlin, but I sure hope so, but have been hoping for about 2 years already...But I am sure it is the manufacturing that is the fly in the ointment...not the ability of the Dendritic Cells to organize an immune response that is safe and effective....thank everyone who has posted one way or the other...I chose this time of night to post to keep the better times open for more informed people to add to the conversation....hope I have....longnwbo
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