The highly anticipated launch of the Insulet (NSDQ:PODD) Omnipod 5 may not come as soon as thought as an FDA review drags on.
SeekingAlpha reported that Insulet CEO Shacey Petrovic, speaking at the Nasdaq Investor Conference, said the regulatory agency will likely not complete its review of the next-generation Omnipod 5 before the end of the year, meaning the launch projected for the fourth quarter of 2021 is now expected for the first quarter of 2022.
When the report came out Friday afternoon, shares of PODD were down 10.6%, but have since rebounded slightly and are trading up 0.5% at $264.54 per share.
News of a delay comes after Petrovic told Drug Delivery Business News this fall that the company anticipated FDA clearance for Omnipod 5 this year, then said in the company’s third-quarter earnings report last month that Insulet remained on track for the regulatory nod for the wearable automated insulin delivery technology by the end of the year.
Omnipod 5 offers a number of market-firsts, Petrovic said, building upon the Omnipod DASH, which was cleared in 2019. With pairing to Dexcom’s G6 continuous glucose monitoring (CGM) system, Omnipod 5 will be the first tubeless, wearable, automated insulin delivery system.
Patients will be able to use a dedicated handheld controller or control the system with a secure app on their smartphone, marking another first, according to the CEO. Recent data presented at the European Association for the Study of Diabetes (EASD) 2021 annual meeting demonstrated significantly improved time in range and reduced levels of glycosylated hemoglobin (HbA1c) in a clinical trial.
According to SeekingAlpha’s report, analysts cited the Omnipod 5 as critical for Insulet’s growth, with news of the delay likely alerting others across the industry to the risk of regulatory slowdowns, while one analyst told the outlet that it could boost rivals in the insulin delivery space, including Tandem Diabetes Care.