Ann: MSB Enters Into $75 Million Non-Dilutive Credit Facility, page-191

Good Article re FDA and Regenerative Medicine :

http://www.nejm.org/doi/full/10.1056/NEJMsr1715626

March 8, 2018
N Engl J Med 2018; 378:954-959
EXPEDITING THE DEVELOPMENT OF NEW THERAPIES

The FDA recognizes the time and effort that go into the creation of regulatory submissions and the effect that working through the regulatory process can have on the time lines for the development of innovative products. Although the FDA has traditionally focused on ensuring the quality, safety, and efficacy of medical products, its mandate has expanded to encompass a role in expediting the development of new therapies, particularly those aimed at serious or life-threatening conditions. The expedited programs — including fast-track designation, priority review, accelerated approval, and designation as a breakthrough therapy — have been successful in accomplishing this goal.⁷ The role of the FDA in facilitating innovation while upholding the agency’s approval standards, especially when it comes to areas of unmet medical need and new technologies, is also clearly expressed in the legislative initiatives contained in the 21st Century Cures Act, which was enacted on December 13, 2016............................