Panion Animal Health AB develops a unique new gene therapy treatment for dogs with drug-resistant epilepsy and the primary targeted market is the USA. The company has just been assigned to a pre-submission conference for this product with staff and experts from the FDA’s Center for Veterinary Medicine to take place in October in FDA-CVM’s office, Maryland, USA. At the meeting, the product will be introduced, the development plan will be discussed, and comments from the experts will be sought for a faster and smoother access to approval and marketing.
The FDA has already received a documentation package about the product, which was included when the request was sent earlier this year, and the FDA experts normally arrive prepared and briefed.
Participants from Panion will be CEO and veterinarian Anja Holm, Director of Business Development Carlos N. Velez, and FDA regulatory expert Dave M. Petrick, plus our scientific experts on a tele-link.
“We are eager to hear the views from the FDA experts, because this will give us a better understanding of the investigations and documentation that are necessary for the approval of our development product” says CEO Anja Holm. “The plan is also to use the trip to US for other meetings with central persons involved in Panion’s business, so we can maximize the outcome.”
Anja Holm, CEO, Panion Animal Health AB