Harvard Apparatus says response from FDA meeting 'very favorable' Harvard Apparatus said in investor presentation slides that its pre-Investigational New Drug meeting with the FDA at the end of January yielded a "very favorable response." The company expects an orphan designation determination by the FDA in Q2. Harvard added that it has approximately two years of capital at current burn rates and no debt. Harvard said that eight patients are using its bioreactor technology with six of those alive at February 2014. The two that did not survive died of unrelated causes, it said. Shares of Harvard Apparatus are up 6%, or 42c, to $7.71 in morning trading.