ACAD
Análisis de JP Morgan, en línea de lo que comentáis por aquí:
Thoughts on (Another) Negative CNN Article Citing FDA Nuplazid Review Upon Follow Up with Mgmt
After catching up with ACAD mgmt following the latest negative CNN article
that indicated further FDA review of Nuplazid’s safety profile, we continue to
believe that the product has a low (but not zero) risk of being pulled from the
market and see today’s headlines as mostly noise (although we can appreciate the
impact of the FDA Commissioner indicating he would "take another look"). Our
views are largely based on the lack of a formal FDA review and the agency’s
initial statement that Nuplazid's safety profile is consistent with the label, as well
as additional mgmt commentary. Although the commercial impact of these
negative headlines remain to be determined (making Nuplazid’s commercial
trajectory over 2018 even more important),
we view today’s reaction as
fundamentally unjustified based on current information.
·
Mgmt believes today's CNN report is nothing new.
Upon speaking to mgmt
this afternoon, we learned that ACAD (including the Head of Regulatory) has
not heard anything new from the FDA following the initial negative CNN
article (see our thoughts here) beyond what was contained in the agency’s
published statement. Recall that that the FDA originally mentioned that
Nuplazid's safety profile was consistent with the label and would continue to be
closely monitored. Further, mgmt strongly reiterated their view that there is no
mortality signal that ACAD is aware of in any analysis undertaken.
·
Ongoing regulatory review of alternative Nuplazid doses could provide
insight into FDA thinking, in our view. The company currently has an NDA
for a 34mg capsule and a sNDA for a 10mg tablet under review with the agency.
The purpose of these alternative dosages is to make doc prescribing easier
(minimize temptation to use half dosing). We suspect these applications may
now also provide an important window into how the FDA views the overall
benefit/risk profile of Nuplazid.
·
Mgmt stated that doc feedback at AAN has been supportive of Nuplazid.
Most physicians reportedly weren’t aware of the original CNN article, and the
ones who were sounded unmoved by it. That said, we believe it's still very much
an open question as to whether a subset of patients/physicians curtail use of the
product, and of course, if the agency’s ongoing review uncovers any more
problematic issues.