Zosano Pharma Corporation the company has been granted a Type C written response only meeting with the U.S. Food and Drug Administration (“FDA”) regarding the resubmission of the M207 (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”) following receipt of preliminary top-line results from the pharmacokinetic (“PK”) study. The PK study included 48 healthy volunteers and evaluated approximately 2,500 samples utilizing lots of M207 produced with two different pieces of manufacturing equipment (“equipment A” and “equipment B”). The study was designed to evaluate safety and the pharmacokinetics of drug exposure levels compared to an intranasal control formulation of two 5 mg doses of zolmitriptan. The safety assessment showed that M207 was generally well tolerated, consistent with previous studies. The preliminary data from the PK analysis showed that there were no outliers with unexpected high plasma concentrations of zolmitriptan, which was a focus of the FDA, as identified in the Complete Response Letter for the original M207 NDA. Drug plasma concentration levels from M207 produced with equipment A were within range and comparable to the intranasal control. Drug plasma concentration levels of M207 produced with equipment B were lower compared to control and to M207 produced by equipment A, but within ranges consistent with approved therapeutic dose levels of zolmitriptan. The FDA had also raised questions regarding differences in zolmitriptan exposures observed between subjects receiving different lots of M207 in the company’s clinical trials. Unless and until the company resubmits an NDA and potentially receives FDA approval, the company is unable to estimate a timeframe for product launch or revenues for 2022, if any, or beyond.