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Michael Taylor: PDUFA outcome seen as long shot for SMMT drug in high-risk FDA trial

Michael Taylor: PDUFA outcome seen as long shot for SMMT drug in high-risk FDA trial
SMMT drug faces high-risk FDA review

Michael Taylor, co-founder and portfolio manager at Agora Trading, described the upcoming PDUFA decision for SMMT as a long shot for what he considers an active drug that underwent development in a high-risk clinical trial structure linked to the FDA submission.

Taylor noted that the trial's primary endpoint does not include overall survival (OS), and said it is known that the FDA is only accepting OS as an endpoint. He added that Harmoni3 is the next study in line and is better designed to demonstrate OS. Taylor also expressed his view that Ivonescimab is effective.

Taylor has recently discussed other notable market developments. He commented on Anthropic's move to lower its IPO valuation from $2 trillion to $1.5 trillion in a prior article. In another update, he outlined his portfolio shift to -50% short and large out-of-the-money QQQ puts, coinciding with volatility reaching 22 as of yesterday.

This material may contain third-party opinions, none of the data and information on this webpage constitutes investment advice according to our Disclaimer. While we adhere to strict Editorial Integrity, this post may contain references to products from our partners.

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