Going 100% with the CRL right after data lock would create a significant risk, as the CRL could pose a last-minute obstacle or setback. We have seen examples like $IBRX and other companies facing such challenges. However, in 2023, with our own MIA certification in hand, we have more control over our destiny through our MAA. This allows us to approach the CRL with significantly reduced risk for the company. It's similar to how TSLA operates, having its own battery manufacturing facility while also outsourcing to third parties. This approach minimizes risks, provides leverage in contract negotiations with third parties, and ensures capacity requirements are met.
$IBRX is a clear illustration of the significant risks involved with relying solely on CRL. it's important to note that every new endeavor has a first one. Just like no company, including BP, has had any success in brain cancer so far, so, if you believe NWBo will fail their MAA based on these circumstances, I wish you good luck!"