@danikabrooks said in Safety Header:
a) We question the use of the term "low" is unsubstantiated/unqualified and does not reflect an adequate tone of caution.
We agree with this assessment.
b) The header is overly selective. Please additionally include "decreased appetite" and "fatigue" with their associated incidences, per page 5 of the PMA. These are all identified in the TMA as the most common TEAEs.
We disagree with this assessment. The header is not saying these are the "most common", just calling out a specific parameter and balancing it.
c) Furthermore, 14.5% is understating the incidence of anemia. Please correct the incidence to 14.6%.
We agree with this assessment.
d) We question the use of "provides" as an absolute. Please revise to "provided" to reflect past study results.
We agree with this assessment.
e) Please disclose the trial in the header.
We disagree; this is not necessary.