NorthWest Biotherapeutics Inc (NWBO)

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Not saying ORBIS is or isn’t involved, but you don’t understand what ORBIS is. What’s new? Go get ‘em tiger.

Here is reality.

While Project Orbis facilitates concurrent review of oncology drugs across multiple regulatory agencies, including the FDA, each participating agency maintains its independence and can make a separate approval decision, potentially leading to a different regulator approving a drug first than the FDA under Project Orbis.

Key points about Project Orbis and approval timelines:

Collaborative review:
Participating agencies share data and review materials, allowing for a faster overall process, but each agency makes its own final decision on approval.

No guaranteed first-mover advantage for FDA:
Even though the FDA initiates the Project Orbis process, another participating agency could potentially approve a drug before the FDA based on their individual assessment.

Faster access for patients:
The goal of Project Orbis is to expedite patient access to new cancer drugs by facilitating parallel reviews across different regulatory bodies.

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