Replies to post #2537 on UniCycive Therapeutics Inc (UNCY)

[Whalatane]

Of course you're right ...very unlikely Ceo will commit to no capital raise before PDUFA....but one can dream / hope as foolish as that may be .
Believe it's all electronic .
First question in next conference call ..." Can you make the July 1st TDAPA cut off if OLC is approved on June 29th " .

Next buying op ....just a wide guess ...if stock tanks on a capital raise . Then the main remaining risk is approval in July
JMO...not investment advice ...just my pre coffee musing
Kiwi

[Whalatane]

From Gemini

Yes, applications for the Transitional Drug Add-on Payment Adjustment (TDAPA) must be submitted electronically through the Medicare Electronic Application Request Information System (MEARIS).
The typical timeframe for a TDAPA application to become effective is approximately 6 months after the quarterly submission deadline, though the exact duration can vary.

TDAPA Application Process and Timeline
Electronic Submission:
All TDAPA applications under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) must be submitted via the online MEARIS platform. Paper submissions are not accepted.

Review Period:
The Centers for Medicare & Medicaid Services (CMS) aims for an effective date for the TDAPA to be one quarter (approximately 3 months) after the effective date of the product's Healthcare Common Procedure Coding System (HCPCS) code, which is usually assigned about three months after the application deadline. This generally results in an effective payment date around 6 months after the application is submitted.

Potential Delays:
A longer evaluation period may be necessary if CMS requests further information or needs a more extensive review to determine eligibility. Inaccurate or missing information can add weeks or months to the timeline.

Payment Duration: Once approved, the TDAPA is paid for a period of two years.

Kiwi