CLAIM #48298 · Pfizer Inc (PFE) · 2023Q3 earnings call · Oct 31, 2023 · due Dec 31, 2024
“You are right, there is an opportunity for an interim analysis around year-end with final analysis second half of next year.”
Mikael Dolsten · President, Pfizer R&D
In context
“then, on your DMD gene therapy program, I think you've previously talked about having interim data by year-end. Is that still the case and does the recent competitor data make you more or less optimistic in your program? Albert Bourla: First of all, let me make a comment that the recent data that we saw about the DMD failures is a very, very bad news for patients. We are really [indiscernible]. I hope there will be a solution for them with the discussion with the FDA, although I can't comment. Now, on our DMD program, I will ask Mikael to comment on that. And then, on the RSV, Angela. Mikael, why don't you start with the DMD? Then Angela, go through RSV? Mikael Dolsten: [indiscernible] we also always said and when someone fails a study. We are very encouraged about getting to the readout. You are right, there is an opportunity for an interim analysis around year-end with final analysis second half of next year. And overall, I think our interim read for DMD have shown a very consistent effect across biomarkers and functional endpoint. And what has been differentiated it so far is that when you look at the functional data we have reported, it has been giving encouraging signals in both the younger and the slightly older boys. And that has not been seen with the other company you referred to. So, in a way, I remain, as earlier, very positive about looking forward to the readout and let the data tell the story. But of course, this makes our gene therapy, in a way, the main game to us. Albert Bourla: Then there was a question, Angela, on the RSV. Angela Hwang: Well, as you heard, during the HCIP discussions, our recommendation for ABRYSVO today is really one around shared clinical decision making. Bu”
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SEC filings for PFE ↗ · Claim quote is verbatim from the 2023Q3 earnings call.