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It's an efficacy issue".
Regarding the safety and efficacy issue, the court cited scientific opinions which made these claims completely unreasonable.
It is thus unlikely that any unexpected general safety or efficacy issue can arise from the use of a well characterized EPO preparation.
Considering the efficacy issue, our results also appeared globally similar to the results of the pivotal phase III EMBRACE trial, with an OS of 11.2 and 13.1 months respectively, and a PFS of 3.8 and 3.7 months, respectively (Table 4).
Trials that assessed this specific efficacy issue recruited patients with short-lasting, less severe disease showing high responses to both experimental and control treatments, thus explaining the lower relative and absolute efficacy estimates (Table 4).
Similar(55)
Because every new drug is somewhat different from preexisting ones, unforeseen safety or efficacy issues may arise during the regulatory review.
"It would be irresponsible to proceed with any clinical use of germ-line editing unless and until the relevant safety and efficacy issues have been resolved," said Professor David Baltimore, the chair of the gene editing committee.
Attrition causes analytical and efficacy issues in weight loss trials.
MOST DRUG candidates fail in the approval process due to safety and/or efficacy issues.
The formation of protein aggregates is one such quality attribute that can lead to safety and efficacy issues in the final drug product.
The healing was complete by the fourth month in our patient but this response may vary due to factors such as bacterial virulence, host immunity and drug efficacy issues.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com