Friday, January 15, 2021 10:35:53 AM
Hardly.
Here's the claim that was made originally:
"“Fast track also means that manufacturing and distribution has already been worked out, so in that way, yes, there are agreements in place."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=160928149
Here's what the guidance that the same poster linked to actually says:
“The sponsor of a product that receives an expedited drug development designation may need to pursue a more rapid manufacturing development program to accommodate the accelerated pace of the clinical program. The sponsor’s product quality and CMC teams should initiate early communication with FDA to ensure that the manufacturing development programs and timing of submissions meet the Agency’s expectations for licensure or marketing approval."
https://www.fda.gov/media/86377/download
I'm sure you can see the difference: the poster claims that all that stuff has already been worked out. For good measure he throws in distribution, which is just nonsense.
The actual guidance says that may need to be done in parallel with the studies.
I do hope you can see the distinction. If not, please let me know and I'll try and help some more.
"Looks like the sun man is wrong again!"
When was the other time that you claim I was wrong on this MB? I'm pretty sure I haven't been , so maybe you have misunderstood the facts again? Give me a chance to explain whatever that was again, please.
"It is difficult to get a man to understand something, when his salary depends upon his not understanding it."
Upton Sinclair
"Nobody ever went broke underestimating the intelligence of the American public."
H. L. Mencken
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