u/Epicurus-fan

From Claude:

Regulatory Timeline
Step 1 — Initial sBLA Submission (Q1 2025)
In Q1 2025, ImmunityBio completed the submission to the FDA of an sBLA for the use of ANKTIVA plus BCG in BCG-unresponsive NMIBC in the papillary indication. The addition of the papillary indication was intended to expand the patient population beyond the currently approved CIS indication.

Step 2 — Refusal to File (May 2, 2025)
This is where the story became contentious. ImmunityBio received a Refusal to File (RTF) letter from the FDA, despite having reached unanimous guidance and encouragement at an in-person January 2025 meeting from the leadership of the Agency — including from CBER, CDER, and OCE — to submit the sBLA. At that meeting, all key decision makers were specifically asked and unanimously confirmed that ImmunityBio should submit the sBLA as soon as possible based on data from the single-arm trial. ImmunityBio publicly challenged the RTF as inconsistent and requested an urgent FDA meeting.

Step 3 — Type B End-of-Phase Meeting (January 2026)
In January 2026, ImmunityBio held a Type B End-of-Phase meeting with the FDA, during which it presented more than five years of follow-up data supporting the papillary disease indication. Based on these discussions, the FDA recommended that the Company submit additional information to potentially support a resubmission of the sBLA. The additional information did not include the initiation or design of any new clinical trials. Topics discussed included current standards of care, challenges associated with chemotherapy, patient management, and data interpretation.

Step 4 — Additional Data Submission (February 2026)
ImmunityBio submitted the requested information in February 2026. After reviewing the additional data, the FDA provided feedback in March requesting updated efficacy data.

Step 5 — sBLA Resubmission (March 9, 2026)
ImmunityBio resubmitted the sBLA to the FDA on March 9, 2026 for ANKTIVA plus BCG in BCG-unresponsive NMIBC with papillary-only tumors. The FDA acknowledged receipt. No new trials were requested. The resubmission included updated long-term follow-up data and bladder-preservation outcomes.

Current Status & PDUFA Timing
As of now, no PDUFA date has been publicly announced for the March 2026 resubmission. The FDA’s review clock for a resubmitted sBLA typically runs either 2 months (Class 1 resubmission — minor updates) or 6 months (Class 2 resubmission — substantial new data). Given that ImmunityBio submitted updated long-term efficacy data, this would most likely be classified as a Class 2 resubmission, implying a potential PDUFA target of approximately September 2026 — though this has not been confirmed by the FDA or the company.

The Broader Context
The regulatory journey for this papillary sBLA has been unusually contentious — an RTF following what the company characterized as explicit FDA encouragement to file raises serious questions about internal FDA consistency. The company’s public pushback and the subsequent productive Type B meeting suggest the path forward is now clearer, but approval is far from guaranteed given the single-arm trial design and the FDA’s evident desire for additional long-term data.​​​​​​​​​​​​​​​​

One of the few good unintended consequences from Trump and Israel's war. High oil prices have increased the price of virgin resin to the point where companies like PureCycle that create recycled resin from poly propylene are now more competitive than ever. And they are not impacted by supply chain issues. From today's conference call: https://stkt.co/lOAIjx9_

https://preview.redd.it/hx1gpw9v1lzg1.png?width=1385&format=png&auto=webp&s=3a8508059c659a3ac00d5da0196a827e14e7af03

Results are out for PureCycle, one of the few public companies actually focused on recycling Poly Propylene. The company is moving away from being a science experiment to an actual business - a first for any recycling company. A company to follow closely if you care about solutions to actually and profitably recycle certain kinds of plastic:

https://feeds.issuerdirect.com/news-release.html?newsid=4951027526953149&symbol=PCT