The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Tyler Martin Van Buren - Cowen and Company, LLC, Research Division - Analyst
: Can you hear me? Sorry, it's Tyler.
I wanted to ask about PULSAR and PHOTON, just a follow-up. Can you elaborate on the decision to randomize patients to the 12-week
and 16-week arms prior to assessing the response to loading doses? Since patients can only be rescued during that first year or move
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AUGUST 03, 2022 / 12:30PM, REGN.OQ - Q2 2022 Regeneron Pharmaceuticals Inc Earnings Call
down in dosing interval and not moved up to a less frequent regimen even though they might be doing well, doesn't this make the
comparison to the (inaudible) study is difficult? And given this, how do you expect to communicate the data to the physicians when
we see it?
George D. Yancopoulos - Regeneron Pharmaceuticals, Inc. - Scientific Founder, President, Chief Scientific Officer & Director
Well, we have to be -- we were somewhat confused by the whole of the business data, and it's meaning its intent. Because of the
confusing study design, we're basically only have to see how well patients are doing. You don't shift them. So if you take your best
patients and you shift them, for example, to a Q12 or Q16 regimen, and we say, X percent of patient concern this regimen, you're
not really understanding how good your drug is and what percent of the patients can actually achieve that dosing regimen. We
know, and we've already published on this that patients who do well can be dramatically extended.
We're trying to answer a very different question, which we think is going to be very, very important to the community, which is
where we can truly achieve extended dosing. And whether you can prospectively put people into these dosing regimens and get
substantial numbers of them to stay at the dosing regimen. Because we're giving the higher dose of EYLEA, which we believe has
this ability to maintain more patients at these longer intervals. So we really believe that this would represent a significant clinical
advance and would also clarify how to use these drugs as opposed to the prior somewhat confusing approaches.
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