Replies to post #286631 on Avid Bioservices Inc (CDMO)

[keep_trying]

Bungler,
Exemption from the premarket notification requirement was in bold, so I presume that was your adder?

Also, premarket in this context would be referring to the technical market that provides for testing reagents, I suppose. That would appear to be referring to FDA approval not being required for a reagent that is being used by an FDA regulated in vitro diagnostic manufacturer.

So it would appear that, in order to sell the diagnostic reagent to a commercial application, PPHM needs to accomplish either some sort of FDA standing for the three categories you outlined from the reg or to sell/partner the sale of the reagent to a party that has approval from the FDA for doing such diagnostic analysis, yes?

The excerpt below is from your post...
(a) Analyte specific reagents (ASR's) (864.4020 of this chapter) are restricted devices under section 520(e) of the Federal Food, Drugs, and Cosmetic Act (the act) subject to the restrictions set forth in this section.

(b) ASR's may only be sold to:

(1) In vitro diagnostic manufacturers;

(2) Clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as qualified to perform high complexity testing under 42 CFR part 493 or clinical laboratories regulated under VHA Directive 1106 (available from Department of Veterans Affairs, Veterans Health Administration, Washington, DC 20420); and

(3) Organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other nonclinical laboratories.

All in all, this doesn't appear to be a problem for near term delivery of the Bavi related diagnostic reagents for sale but for the need to make the sale to the qualifying facilities. However, the qualifying facility may need to go through some sort of FDA review for the use of a new reagent, would they not? Hence, a role for partnering with PPHM?

Best wishes and IMO.
KT

[Protector]

Bungler, so actually we could see the proof of concept as a late stage if we don't have to go through an FDA approval cycle.

That means, if I understand it well, that PPHM can sit down, hammer out an agreement with the potential candidate, and shortly there after start working on production, marketing, sales, etc with the partner WITHOUT ANY FURTHER ADMINISTRATIVE DELAYS.

Pls correct me if I am wrong on this as I think this is important for all of us. I saw your reply to KT but I am kind of fishing for a Bungler self-made phrase translating the regulation in one applicable sentence: NEED or DOESN'T NEED APPROVAL (possible with conditions such as when certifying or partnering with a certified party, etc). TIA.

[biopharm]

Bungler, below talks about genome editing "reagents" and now I wonder if any include some PS Targeting properties...

http://www.nextbigfuture.com/2017/02/crispr-gene-editing-is-undergoing-rapid.html?m=1