Biotech Values

[jbog]

jq1234,

FDA had given the statistics for years that NDAs submitted at end of qtr/half/year have more deficiencies than NDA submitted at other times. Thus it showed companies rushing NDA submission.

The point I was trying to make is that if the FDA gave a liaison to the company, any deficiency should be caught upfront prior to submitting. This whole process can be a black or white situation if the proper guidelines are issued.