Replies to post #3325 on PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[midastouch017]

Covid travel restrictions that are
hitting a bunch of companies.

.... and to my amazement even US companies
get hurt too!
Funny, is the FDA confined to stay put in
their offices, or do they work only from home
nowadays?

The intrinsic value, near term and the
proposition of the company haven't changed.

I tend to agree, my only doubt is, will the FDA
be able to examine PLX premises by 27Th Apr 2021?
Seems to me Covid does not plan to vanish in the
near future.

[midastouch017]

PLX is not alone:

Novartis receives complete response letter from U.S. FDA for inclisiran

https://www.globenewswire.com/news-release/2020/12/18/2148121/0/en/Novartis-receives-complete-response-letter-from-U-S-FDA-for-inclisiran.html

December 18, 2020 16:50 ET | Source: Novartis International AG
The U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related conditions
No onsite inspection was conducted of the single third-party facility in question. If a facility inspection is needed, FDA will define an approach once safe travel may resume based on public health need and other factors
Novartis will work with FDA and the third-party manufacturing facility in Europe to complete the inclisiran review, to bring this potential first-in-class siRNA to patients in the U.S. as quickly as possible
Basel, December 18, 2020 — The U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of December 23, 2020, due to unresolved facility inspection-related conditions. The conditions will be conveyed to the European manufacturing facility within 10 business days. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the Novartis NDA may be approved. No onsite inspection was conducted. If it is determined that a facility inspection is needed to approve the application, the FDA will define an approach for scheduling once safe travel may resume based on public health need and other factors.