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Re: DavidLeeRoth post# 3897

Tuesday, 02/27/2024 4:36:27 PM

Tuesday, February 27, 2024 4:36:27 PM

Post# of 4209
IMC-2 Long-COVID Development Program: We have clarity from the Food and Drug Administration (“FDA”) on the development requirements for advancing IMC-2 (combination of valacyclovir and celecoxib) into Phase 2 development as a treatment for LC symptoms. As noted above, we expect to receive top line results from the ongoing Bateman Horne Center independent investigator supported study in the second half of 2024. There continues to remain a high unmet medical need for treating LC symptoms. Recently, a USA Today Health article reported that federal estimates suggest at least 16 million Americans have LC and as many as 4 million of them are disabled by it. There are currently no FDA approved LC treatments. We are excited that IMC-2 has the potential to be one of the first approved treatments for LC and are exploring various means by which to fund execution of the important Phase 2b IMC-2 trial.
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