Our client was working with a family office which had invested in a novel IV formulation of a repurposed asset for the treatment of ischemic stroke. With a promising completed phase II clinical trial and an ongoing phase III in Europe, our client was seeking to understand how the FDA would view this data, and whether any separate US trials or integration of US sites into the ongoing trials would be required to support the asset's approval in the US. They also wanted to understand whether they could obtain orphan drug designation (ODD) or any other approval that would allow for a faster approval in the US. Our client reached out for support in managing a pre-IND meeting with the FDA to discuss these matters.
We brought in our expert regulatory consultants to lead interactions with the FDA in securing a pre-IND meeting acceptance and scheduling the meeting. Firstly, we gathered any relevant information from our client which would be useful in building the Meeting Request Letter. We also enlisted clinical specialists from our network to advise and assist in building the documentation. We provided support in preparing a briefing package. We participated in the meeting and helped support FDA interactions both during and after it, and helped prepare responses to the FDA.