I thought the same, and recall that MT said 150 parties had signed up to watch, including BP and various research organizations, good info to get out prior to hitting the road this weekend, to start a few months of conferences etc.
I have been ding some research on how the clinical hold may effect BP making a move. Termination clauses are very common in bio partnership deals, in fact they are the norm. [I can post some stuff showing this if anyone is interested]
With this in kind I asked Grok Deep search to look for other companies who experienced a hold and use that info to present a possible deal.
Key Points
A big pharma could partner with Neurizon Therapeutics for NUZ-001, an ALS drug under FDA clinical hold, with an upfront payment and milestone payments tied to resolving the hold, completing a combined Phase 2/3 trial, gaining FDA/EMA approval, and achieving sales targets, followed by royalties.
The deal includes termination clauses if the clinical hold isn’t resolved within a set time, protecting both parties.
With 50% penetration (17,500 patients) at $100,000 per year, annual sales could reach $1.75 billion, making it a potential blockbuster despite the small patient base, which is notable given the rarity of ALS. [Patient numbers have been reduced by 50% to be conservative and are based on the US and EU]
Partnership Deal Overview
A hypothetical partnership deal between a big pharma company and Neurizon Therapeutics for NUZ-001, an ALS treatment currently under FDA clinical hold, would involve financial and strategic support to address regulatory hurdles and advance development. The deal would include an upfront payment to secure rights and fund initial efforts, progressive milestone payments tied to key development stages, and royalties once the drug is marketed, with clauses to manage risks.
Financial Structure
Upfront Payment: An initial payment to Neurizon to secure rights and support efforts to resolve the FDA clinical hold, reflecting the added risk due to regulatory uncertainty.
Milestone Payments: Payments tied to specific milestones, including:
Resolution of the FDA clinical hold, enabling trial progression.
Achieving breakthrough therapy designation, potentially speeding up approval.
Starting the combined Phase 2/3 trial, consolidating development phases for efficiency.
Successfully completing the Phase 2/3 trial, demonstrating efficacy and safety.
Gaining FDA approval, a critical regulatory milestone.
Gaining EMA approval, expanding market access.
Reaching specific annual sales targets, incentivizing commercial success.
Royalties: A percentage of net sales once the drug is marketed, with a tiered structure to increase as sales grow, balancing rewards for both parties.
Termination and Escape Clauses
The big pharma can terminate the agreement if the clinical hold isn’t resolved within a specified timeframe, such as 18 months, to manage prolonged regulatory delays.
Standard clauses allow either party to terminate for non-performance, ensuring flexibility if development faces significant hurdles.
So I'm hope full a deal can be done. As always no guarantees.
Cheers
(20min delay)