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DragonBear

01/07/20 11:21 AM

#112091 RE: spiritthing #112088

Not sure I accept the insinuation that this means nothing

It has meaning to FDA employees...

Linky

Who are restricted from holding financial interest in SROs?

FDA employees as well as their spouse and minor children are prohibited from holding financial interests, like stock, in certain businesses regulated by FDA. This includes many companies working in the drug, biologic, medical device, food, and tobacco industries, among others...

What is the SRO list?

To help employees determine whether or not an entity is considered to be an SRO, FDA maintains the List of Significantly Regulated Organizations (SROs). This is a searchable list of publicly-traded companies (traded on U.S. as well as foreign stock exchanges) that it has determined to meet the definition of an SRO...

How often is the SRO List updated? How can I see the updates?

The list is updated monthly.



There's no evidence the listing is recent. There are no dates given as to when a company was first listed.

Even if it is as you say it means we are a lot closer than we thought and FDA is prepared and on top of the situation when things come to fruition



No, it does not say that. The FDA does not prepare for mythical IND filings. It receives a filing. And then reviews it. The FDA is not in the business of predicting or anticipating when an IND is filed.

TBonePickems

01/07/20 11:21 AM

#112092 RE: spiritthing #112088

No negative insinuation; I think it's fabulous that they are on an FDA published list of vendors that may produce a product that needs FDA regulation. Nothing bad about that at all. Just pointing out that i'm not willing to take the leap that the date on that page correlates to some recent action/filing by PMCB with the FDA...for reasons stated. It could, and once again, I hope it does.