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Re: dmb2 post# 458582

Monday, 04/11/2022 2:27:31 PM

Monday, April 11, 2022 2:27:31 PM

Post# of 700483
dmb, it’s interesting that we can all read the same thing and each come away with different ideas of what is said based upon our own point of view and experience. I wouldn’t have thought that consumables leaching would be an issue until the professor raised it, but it seems likely that some assurances would be a part of the new supplier agreement. I think you’re right, and it makes sense that it would simply be a perfunctory task, particularly if Saint Gobain is the new supplier, since they’re as established as Corning in plastic lab supplies. (note: Saint Gobain supplied the consumable bags for the DCVax-direct trial) This testing would probably be more of an issue for a lesser-known supplier, or if they were selling Flaskworks as a medical device, which the professor didn’t know.

I believe closing and automating processes is more commonly done in conjunction with a marketing application or post approval, but Northwest Bio seems to blaze their own (slower) path, so if I had to guess, right now I would say that Flaskworks approval for investigational products will come before marketing approval, but I agree that it will be interesting to watch how this is unfolds.



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