Challenge:

A biotech company with a novel oral drug delivery technology platform was looking to out-license its lead asset, a reformulated generic therapeutic in a new, non-opioid pain, indication, which had recently completed Phase II clinical trials.

Solution:

Alacrita conducted a detailed review of data-room contents and additional materials supplied by the client and held further discussions with the company to seek clarification and amplification around key issues. Alacrita compiled its findings and recommendations into a report describing the nature and level of each issue arising from the review. Although the dossier was found to be in good shape, we identified a number of minor errors, omissions and inconsistencies and made recommendations to correct and complete the dossier.