PROTALIX BIOTHERAPEUTICS, INC. (PLX): Hoping for manufacturing issues: Defi...

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PROTALIX BIOTHERAPEUTICS, INC. (PLX)

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Re: midastouch017 post# 3514

Wednesday, 04/28/2021 6:27:36 AM

Wednesday, April 28, 2021 6:27:36 AM

Hoping for manufacturing issues:

Deficiencies (plural) could relate to manufacturing issues but would not seem to make sense if it were the drug itself. We should know soon with the Balance data.

Also this four year old article talks about the FDA increases for CRLs as of some years ago due to manufacturing issues:

"In 2016 the number of complete response letters issued spiked to a three-year high, largely due to increased concerns related to manufacturing facilities"
https://www.fool.com/knowledge-center/what-is-a-fda-complete-response-letter.aspx

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