I have not posted on PIQ for a very long time…but the FDA...

I have not posted on PIQ for a very long time…but the FDA decision, announced yesterday, that an application for PromarkerD through the De Novo pathway classification is appropriate, has potentially far reaching consequences for this stock . If the application is approved, it should allow the Company to charge premium disbursement rates over current, less efficacious therapies which are the gold standard such as eGFR and uACR. I note that current guidance from the ADA suggests that testing of all standard risk patients could move to a biannual event , see link to abstract below:

https://care.diabetesjournals.org/content/44/9/2000

” The Kidney Health Evaluation for Patients with Diabetes is a new quality measure that requires eGFR and uACR testing annually. In this study, 89.5% satisfied the medical attention for nephropathy criteria compared with 54.2% that satisfied the criteria for eGFR and uACR in the past year. One area for potential improvement is continued adoption of the new Kidney Health Evaluation for Patients with Diabetes measure , which could help improve adherence to guideline recommended testing. In fact, since 2020, ADA guidelines recommend monitoring eGFR and uACR twice annually in patients with diabetes and uACR >300 mg/g and/or an eGFR 30–60 mL/min/1.73 m2 (10,39).”

I note that the current guidance re pricing for PromarkerD from the Company is around $150 (based feedback from a market access study- latest presentation slides of Company website ) with royalty rates of 5-15%…If the application is successful, approval using this pathway may allow the higher end of the range pricing …possibly even above this guidance.
I have also read that new shorter timelines apply to certain categories of De Novo applications ….which combined with all the other good news this company has produced recently, makes me think a rerating is just a matter of time . Great little Company totally off the radar. OP


https://www.morganlewis.com/pubs/2021/10/fdas-long-awaited-de-novo-classification-rule-is-finally-here

Good luck to all shareholders. Please do not rely on any opinions or facts given in the above post when making an investment decision.