#Omer stock plusThen we must all wait another 30 days plus however long it takes to work through "any required follow-up". Narsoplimab's HSCT-TMA application is stalled until it can supply unspecified "additional information". What could be worse? Now shareholders are in Never-Never Land. According to FDA’s interim response, the deciding official is collecting additional information, and a response to Omeros’ appeal will be provided within 30 days from the date that the additional information is collected and any required follow-up is conducted by the deciding official. Per FDA guidelines for formal dispute resolution, a final decision from OND was to be rendered within 30 calendar days of the meeting unless the deciding official in OND required additional information. As part of FDA’s standard procedures for dispute resolution, Omeros and OND met last month to discuss the appeal. Omeros issued an press release advising:įormal dispute resolution is an official pathway that enables a sponsor to appeal a decision by an FDA division to a higher authority within the Agency, in this case the Office of New Drugs (OND). Unfortunately, the response was another puzzler. In fact, the FDA did respond as scheduled on. The process is designed to move quickly with an FDA response expected in early 08/2022. It submitted its dispute resolution briefing package to the FDA in early 06/2022. Instead it opted to go forward with an adversary dispute resolution process. It determined that there was no way to penetrate the FDA through normal channels. In response to the CRL, Omeros' management threw up its hands. The latest word from the FDA on narsoplimab in treatment of HSCT-TMA is opaque While I held to a hope that narsoplimab might still get approved in treatment of HSCT-TMA, such was not to be. During Omeros' Q2 earnings call, it offered no satisfactory explanation for the FDA's newfound hesitation. It gave the following as the reason for its extension:Īs part of the ongoing BLA Priority Review, Omeros recently submitted a response to an FDA information request, which the health regulator has classified as a major amendment requiring additional time to review. The bloom came off the rose on when the FDA extended its action date to. The seer who played Omeros well, selling its enthusiasms >$20 and buying the doldrums <$12 during this three-year period did very well indeed. It zigzagged happily between a high share price of ~$24, with a market cap approaching $1.3 billion it sported a comfortable floor of ~$10 with a low market cap of $0.5 billion. In early 05/2021, they approved International Classification of Diseases (ICD-10) codes for narsoplimab in treatment of HSCT-TMA to take effect in 10/2021.ĭuring the period from 01/2018 to 09/2021, Omeros stock responded buoyantly as shown by the chart below: Narsoplimab in treatment of HSCT-TMA seemed destined for quick approval optimists might even have hoped for a positive nod in early 07/2021. The FDA indicated that there would be no call for an advisory committee meeting to discuss the BLA. It was awarded priority review with a PDUFA date set at. It culminated with the excitement of being the first therapy in treatment of HSCT-TMA to be submitted to the FDA in 01/2021. It continued up through its successful clinical trials. It began happily enough back in 2018 with FDA grants of breakthrough therapy and orphan drug designations. Omeros' timeline for narsoplimab as a treatment for HSCT-TMA in front of the FDA has been painful for shareholders. Omeros' shareholders have been roughed up as its lead therapy struggles for FDA approval. In this article, I discuss the new development and its impact on Omeros as an investment. Today () as I write, the FDA has opened a new chapter in the Omeros story. I have been following its long efforts to secure FDA approval for narsoplimab, most recently in " Omeros: Follow The Bouncing Ball" (" Bouncing"). Omeros ( NASDAQ: OMER) is one of my favorite small biotechs.
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