A client had two CRL letters to show for two submissions of their metabolic disease asset. The issues involved phase 3 safety & efficacy data critical for approval and subsequent licensing. As product was to be discussed at FDA’s EMDAC prior to approval, Vault Bio was hired to conduct full diligence on NDA submission quality and ability to be approved.

• Evaluated entire data package and recommended shift in strategy to enhance benefit/risk profile.
• Implemented strategy and assisted in developing the EMDAC Briefing Document and helping guide FDA meeting prep.

EMDAC strongly voted to recommend product approval in T1D (13-1) and in T2D (14-0) based on Briefing Document and meeting data presentation, ultimately enabling a commercial licensing deal.

CEO hired Vault to provide diligence on an asset in light of a potential acquisition. Vault conducted commercial value diligence to identify key risks and upside opportunity.

• Vault performed rapid asset analysis based on differentiating drug attributes and competitive considerations. Several critical risks and potential upsides were identified.
• Vault built an analytical case to compress the downside and shift significant potential value from the seller to the buyer.
• Partnered with the internal BD leads to develop negotiation and deal-terms highly favorable to the client.

Based on the deal, the client was a finalist for ‘Licensing Deal of the Year’ for the innovative deal structure. The product was licensed, launched, and performed to the downside case per the identified risk. Because of the risk mitigation and deal-structure, the losses were negligible.

We have helped small pharma, biotech, medical device and digital therapeutics startups through global enterprises design and develop highly differentiated products, build and sustain better brands, and forge stronger businesses.