In the pooled primary analysis set
, the median duration of response was not reached at time of analysis with responses ranging from 1.6+ to 38.7+ months and 75% of patients having a duration of response of 12 months or longer.
Notably, in the full analysis set
, pimavanserin showed significant improvements on two pre-specified measures of negative symptoms: the secondary endpoint PANSS negative symptoms scale sub-score (unadjusted p=0.0474) and the exploratory endpoint PANSS Marder negative factor score (unadjusted p=0.0362).
An 18 month follow-up analysis of the company's CHRONOS-1 showed an ORR in the full analysis set
population of 60.6% and in the MZL histology an ORR of 78.3%.
The integrated analysis includes 1,161 FASENRA patients, of whom 1,030 are in the SIROCCO/CALIMA/BORA full analysis set
and 131 are in the ZONDA/BORA analysis set
We also recommend incorporating these guidelines into drafting new patent claims and amending pending claims to overcome the revised eligibility analysis set
forth in the guidelines.
The analysis set
forth in Westmas precludes granting immunity to Fryed as an "agent."
Eight months later, OCR sent a follow-up notice to UHCO's Privacy Officer notifying her that the security assessment executive summaries she had provided did not depict an enterprise-wide evaluation of all potential threats and vulnerabilities and therefore did not meet the requirements for risk analysis set
forth in the HIPAA Security Rule.
If that had occurred, the Plaintiffs' constitutional claims would have been moot, without requiring a court to rule on them at all.<br />Accordingly, under the two-step analysis set
forth in Bennett, Congress intended to divest district courts of jurisdiction to hear the claims pursued by the Plaintiffs and instead intended those claims to be brought under the statutory review scheme established by the Natural Gas Act.
The full analysis set
(FAS) (n =11) included patients randomized to treatment who received at least one dose of the assigned treatment.
Three patient populations were analyzed: the full analysis set
(FAS), the nail psoriasis set (NPS), and the scalp psoriasis set (SPS).
For the ITT analysis, a full analysis set
will be used, and all subjects randomly allocated to one of the two groups, have taken at least one dose of the investigational drugs, and have reported once at least the primary outcome after the baseline will be included.