Replies to post #113129 on Biotech Values

[genisi]

So what is your understanding of chapter C in #msg-59147723?

C. When is an amendment classified as minor?

Except for those amendments that are classified as major or telephone, amendments will be designated as minor. Minor amendments often consist of deficiencies that are outside the control of the applicant or deficiencies that are more easily addressed than those in a major amendment. Though most amendments will likely be minor, some examples include, but are not limited to:

[kaivamei]

Regarding "minor" note this wording
in the material kindly posted by hptaxis:

"Minor amendments often consist of deficiencies that are outside the control of the applicant..."

This supports the idea that a deficiency that is "minor", like a list of questions that is "short", does not necessarily mean that the problems with the application will be easy to remedy and that approval is imminent.

Thanks hptaxis, Dew, and genisi for the helpful replies.


(Sorry if this had been covered before.)