Theralase Technologies Inc. V.TLT

IBRX Crashes as FDA issues CRL

[enriquesuave]

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.  We 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.

[enriquesuave]

https://seekingalpha.com/news/3969942-immunitybio-stock-crashes-after-fda-snub-cancer-therapy?mailingid=31446778&messageid=2900&serial=31446778.323&utm_campaign=rta-stock-news&utm_content=link-3&utm_medium=email&utm_source=seeking_alpha&utm_term=31446778.323

[enriquesuave]

https://criterionedge.com/manufacturing-and-immunogenicity-are-key-considerations-for-approval-of-biological-products-bla-vs-nda/

[DJDawg]

Sorry for the IBRX investors. We have all been there. One thing I will say is that the huge pre-market price drop on this specific news and a similar process with SESN when it lost all value suggests that, with publicity, the market considers a NMIBC treatment very valuable. IBRX is down more the 1B in market cap pre-market just for this specific failure.

[DJDawg]

Once again, I'm so so glad that Ruvidar is not a biologic agent being made in a bioreactor. So many manufacturing and quality control challenges.

[ScienceFirst]

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

[ScienceFirst]

Theralase's molecule is considered a NBD, unlike IMMUNITYBIO that is a BLA and much more complicated to receive approval. Ferring's approval for its gene therapy that was was finally approved in Nov. 2022 was also delayed by 2y in 2020 as it was also a BLA. So, a much less stringent approval process when it comes to evaluating the manufacturing process of TLD1433 (Ruvidar). Key

[ScienceFirst]

Theralase's molecule is considered a NDA, unlike IMMUNITYBIO that is a BLA and much more complicated to receive approval. Ferring's approval for its gene therapy that was was finally approved in Nov. 2022 was also delayed by 2y in 2020 as it was also a BLA. So, a much less stringent approval process when it comes to evaluating the manufacturing process of TLD1433 (Ruvidar). Key

[enriquesuave]

Any Big Pharma wanting to partner with us will love the fact that an NDA and manufacturing for our drug is vastly more advantageous than a biological drug.  Ease of production and much lower risk for approval IMHO.   "Manufacturing of Biological Products is Inherently Riskier than Production of Drugs. The manufacturing processes for biological products are different than

[CancerSlayer]

  Our competition is weakening by the day...either by suboptimal efficacy or initial rejections/CRLs.  Couldn't have a better scenario for TLT.   In addition to the suboptimal 23% & 19% 12 month CRs for Adstiladrin & Keytruda, respectively, there are some lackluster preliminary results from Janssen's (Pharma division of J&J) Ph 2 SunRISe-1 study, which