Lets not forget there are thousands of other companies with thousands of products, techniques and devices all clamouring for the attention of FDA and/or CMS .
Take a look at a Urology Journal or any other medical publication that supports peer reviews and you will find that anything in the cancer or medicinal line is surrounded by other items all trying to get a foot in the door. Midkine will be seen as a possibility for fixing or diagnosing some things but at the same time plenty of others will be finding something else that may or may not work.
Its a matter of getting a whole cartload of peer reviewed material and validation in front of them.
Anything that threatens the status quo will be subjected to further scrutiny as in PEBs changing of clinical procedure.
The good part is that all the peer reviewed material that PEB is producing validates Midkine for CDY at the same time, as it is part of the cxBladder test.
A quick glance through the procedures at CMS for LCD determination is fairly enlightening but details require permission.
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