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David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: “When the market opportunity is limited, finding investment becomes the key issue”. He mentioned other problems as well: “Very low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome”.[1] Clearly, Continue reading Draft FDA Guidance for COCCIDIOIDOMYCOSIS
Now, I know we should not make light of any IDSA Guidelines, far from it. This latest, the Aspergillus Guideline [1], like others before, is a thoughtful document which reviews the newest information and reflects expert authoritative thinking on the subject. It also is a hefty 60 pages long, as Continue reading Aspergillus_Guideline.ZIP
Isavuconazole is a potent triazole; like Voriconazole, it has garnered an indication for invasive aspergillosis. However, it failed where other azole antifungals succeeded: in a pivotal trial, not yet published, the drug was inferior to Caspofungin in the treatment of invasive candidiasis/candidemia in non-neutropenic patients [1]. To provide some background: in Continue reading The Cresemba Candidemia Gamble – Rien Ne Va Plus