7
Stakeholder Comments
4. (cont)
We agree that changes to reflect at least some of these points are appropriate, and have
proposed modifications of the SMPR applicability statement to provide better clarity However it
.
,
is worth noting that, as can be inferred from the excellent comments, that expectations for
methodology capable of excluding modified amino acids without fail are likely unrealistic.
Nonetheless, clarification of the goals does provide, at the very least, additional basis for
comparative evaluation by the ERP, by making the ability to select against modified forms an
additional point of method differentiation.
Questions??
