Fast track approval and positioning ...Ms. Papineau has over 30 years' experience in quality and regulatory affairs with Baxter, Boston Scientific and Cogentix (Vision-Sciences) … has successfully prepared dozens of FDA premarket submissions and European Union (EU) technical files to support CE marking of a broad spectrum of medical devices … Pam will work with Hogan Lovells, the Company's legal Counsel, preparing for a pre-submission meeting with the FDA and follow-on activities through the regulatory approval process.
IME should be an excellent candidate for the FDA’s EAP (Expedited Access Pathway) program. For starters:
1) the contrast agent is already FDA approved and the following criteria are already met:
2) ' represents a breakthrough in technology;'
3) 'no approved or cleared alternatives exist' and
4) ' IME offers clinically meaningful advantages over existing approved or cleared alternatives including the potential, when compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or the availability of which is in the best interest of patients.)'
When it comes to potential buyout suiters don’t forget that Baxter is one of the biggest in the hospital products business and is the biggest supplier of an existing line of urological solutions and sets ... and has the largest sales force in the business.