RE:IBRX Crashes as FDA issues CRL EnriqueSuave ... Great catch. And you are correct to say that TLT won't go through such issues because we are a NDA, not a BLA.
This site clearly explains the huge differences between both:
What are the Regulatory Differences Between an NDA and BLA?
https://www.allucent.com/resources/blog/what-are-regulatory-differences-between-nda-and-bla#:~:text=To%20formally%20request%20approval%20to,to%20traditional%20small%20molecule%20drugs.
Key Differences Between BLAs & NDAs
While BLAs and NDAs serve the same purpose of gaining approval to market a drug in the United States, they differ slightly in terms of their application content and submission requirements. Regarding approval criteria, NDAs must fulfill three conditions:
- The drug is safe and effective for the proposed use and that the benefits outweigh the risks
- The labeling is appropriate and contains all necessary information about the drug
- Manufacturing methods preserve the drug’s identity, strength, quality, and purity
Similarly, contents of a BLA should establish that the biological product is safe and potent; however, because biological products are processed from living material, BLA content must also demonstrate purity specifically in terms of showing that the final product does not contain extraneous material. Due to the complexities of manufacturing biological products, a pre-license inspection of the facility is generally required before a BLA is approved. Pre-approval inspections sometimes also take place during an NDA review, but are typically conducted based on risk assessment by the Agency. Once a BLA is approved, the Sponsor is granted a license for the biological product, which permits its introduction into interstate commerce per Section 351 of the PHS Act. This licensing process is not a part of the NDA, as drugs that are approved by NDA are regulated only by the FD&C Act, and not the PHS Act. Until very recently, certain biological products could be approved under an NDA rather than a BLA. However, according to the Biologics Price Competition and Innovation Act (further discussed below) this is no longer the case, and all biological product approvals now occur through a BLA.
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enriquesuave - (5/11/2023 8:39:01 AM)
IBRX Crashes as FDA issues CRL
N-803 plus BCG rejected by FDA citing manufacturing issues. A BLA is always more complicated. Adstiladrin also had received a CRL and it took almost 2 years to address manufacturing issues before they were approved. TLT will only have to file an NDA which is a 1000 times easier, and manufacturing is basically a non issue. IMHO. Make room for Ruvidar.