NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

After reading the 10-Q, I was wondering how long the regulatory review process for the SAP could take. Anyone know if this is the correct manual and table? TIA


CDER Manual of Policies & Procedures MAPP

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-manual-policies-procedures-mapp


OFFICE OF NEW DRUGS
Good Review Practice: Good Review Management Principles and Practices for Effective IND Development and Review

https://www.fda.gov/media/85790/download

Presently, CDER does not have the resources to meet all listed timelines, and must balance this work with other responsibilities, including NDA/BLA review and oversight of postmarketing safety. Meeting all the dates specified in Tables 6 and 7 cannot be accomplished at present. However, CDER has selected several high-priority submissions from these tables and will work toward implementing the goal date over the next several years for these submission types. The high-priority submissions include new phase 2 and phase 3 adaptive trial designs, new phase 3 protocols, and postmarketing requirement protocols (for required postmarketing studies and trials that concern complex designs or statistical assessments).


Table 6. IND Drug Development Submissions (Corresponds to Submission/Amendment Category 3) (Page 36 of 42)


Description / / Recommended Timeline / / Type of Evaluation / / Communication With Sponsor


Statistical analysis plan / / Up to 60 days / / Written review / / As needed