The Waiting Game is a powerful documentary that explores the untold story of the ABA/NBA merger, revealing a battle for justice.

There are four criteria that have to be met by the startup: HCT/P’s have to be minimally manipulated, “be intended for hodmologous use only, not be combined with a drug or device, not have a systemic effect” (FDA, “Guidance for Industry” 2). The most important requirement under Title 21 of the Code of Federal Regulations (CFR) Part 1271 is that HCT/P’s have to be minimally manipulated (FDA, “Minimal Manipulation”).

However, the criterion of minimal manipulation is especially complicated; therefore, it is necessary to ensure that materials used for decellularization of scaffolds are not considered adipose-derived tissues, which is prohibited under Title 21 CFR Part 1271 (FDA, “Minimal Manipulation”). Before investing in the startup, it is important to realize that all decellularized materials undergo an extremely harsh FDA approval process. Even though cell-derived matrices were produced since the 1990s, only five companies were granted FDA approval for the use of decellularized tissues in humans in 2014 (Cheng et al. 462).