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Re: FDApproved post# 18557

Monday, 11/19/2018 9:52:08 PM

Monday, November 19, 2018 9:52:08 PM

Post# of 44784
"IMO..They (DoD) Cannot Buy One Without The Other, As Common Sense Dictates The Auto-Injector Will Be Filled With PLX-R18 In Pluristem's Aseptic Fill & Finish Line Right At The Factory Then Cryo-Frozen For Long-Term Storage Or Possibly Lyophilized And Filled In The Auto-Injector For Long-Term Storage. It Will Be One Or The Other Depending How far Along They Are With The Lyophilization Technology." -fdapproved


Ok, earth to fdapproved… so, just like that, eh? Take that over there, pour a little into this injector thingy, throw it in the freezer or dehydrate it into a power, whatever, and start injecting nuclearized soldiers... Botta boom, botta bing. Just like that. OMGOMGOMG...

Um, silly question, but do you think the FDA might want to do a study with this new happy meal combo you describe? Lyophilized? I'm almost positive, that will just slide on in and by any need for bioavailability testing, storage integrity, etc. etc. etc. etc.

Should have this buttoned up in a couple of weeks or so?! Sounds like it.

Geesh. As Common Sense Dictates