Embedded Files
The searchable repository is a work in progress while the team builds up our collection of regulatory submissions. For now, we are providing examples of documents that were generously donated.
The searchable repository is a work in progress while the team builds up our collection of regulatory submissions. For now, we are providing examples of documents that were generously donated.
Case Study: allena pharmaceuticals
Case Study: allena pharmaceuticals
In this recent biotech bankruptcy case, two entire CTD files were transferred for $25,000 each. The cost of generating this data from scratch can range from a few million for an IND to hundreds of millions for an NDA/BLA.
Individual CTDs can span thousands of pages of detailed chemistry, manufacturing, controls, preclinical, and clinical data, each representing millions of dollars in investment.
You can access the full dossiers donated by Lumen Biosciences here.
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