By comparison, 80% of patients in the cisplatin group responded overall, with 38.6% complete responses
After multiple injections in the immunosuppressive tumor model, complete response
rates increased to a majority of the treated animals.
The primary endpoint of the trial was durable complete response
Patient receiving Erythromycin in group B after 1st week 9 patient have no response, 21 Patient have response 2nd week 6 have complete cure 24 have partial response after 4th week 16 have partial response and 14 have complete response
after 6th week 8 have partial response 22 have no response.
The statement issued by Jazz Pharmaceuticals noted that the FDA's "complete response
letter" said the new drug application for sodium oxybate cannot be approved "in its present form" and cited the need for more clinical studies.
Savient said it had received a so-called "complete response
letter" from the FDA stating that the FDA "can not at this time approve" its application for the drug as a treatment for chronic gout.
In the overall intent-to-treat analysis, 92% of patients who had complete response
at 1 year maintained complete response
at 2 years.
The primary endpoint of the trial is the proportion of patients surviving at least 90 days that achieve a complete response
when Prochymal is added to steroid therapy as compared to those receiving steroids alone.
Cantor Fitzgerald analyst Alethia Young cut her price target on Sarepta shares to $175 from $231 after the company announced the receipt of a complete response
letter, or CRL, on golodirsen from the FDA.
M2 PHARMA-November 14, 2018-Pain Therapeutics petitions US Food and Drug Administration regarding Remoxy complete response
Of 29 study participants at a median follow-up of 15.4 months, 19 (66 percent) had either a complete or partial response, with 15 (52 percent) having a complete response