Jeff $KPTI Headline Looks Far Worse Than It Is- Partial
Hold Just An Administrative Blunder
On March 10 KPTI announced lead drug selinexor was placed on partial clinical
hold pending proper updating of trial forms. After speaking with mgmt, we
are comfortable this was purely an administrative error, does not at all reflect
any new safety issue, and should not materially affect trial conduct/enrollment
timelines. We expect swift resolution and while perhaps not favorable for
credibility, we see no impact to sel's potential and would buy on weakness.
Partial clinical hold purely due to an administrative issue. After the close
Friday, following some initial chatter about several ISTs of selinexor being suspended on
clinicaltrials.gov, KPTI announced that FDA has placed a partial clinical hold on the drug.
After speaking with management, our understanding is that this is due to an AE table that
had inadvertently been removed from the investigator's brochure and informed consent
forms used in the trials in a recent version. FDA requested that the table be updated and reinserted,
and KPTI has provided that updated information. Our understanding is that this is
purely an administrative blunder, and that there have been no new safety issues or deaths
from the drug. While this is not favorable for their credibility regarding trial conduct, we
believe the company has taken action to improve their processes such that going forward
human error should not cause another minor setback in their development program.
Should not materially impact trial conduct or timelines. Based on the rules of
the partial clinical hold, new patients may not be started on selinexor clinical studies, and
patients progressing on the drug must stop taking selinexor. We note, though, that in most
of the trials, progressing patients are typically taken off the drug anyway, so this should not
change studies' integrity. FDA has 30 days to respond, and assuming things go smoothly,
the matter could be resolved within days to weeks and at least for the ongoing companysponsored
trials, therefore should not meaningfully change enrollment timelines.

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