Filing an FDA NDA is not material because the outcome is uncertain.
In a bit of research confirmed that 98% of companies do disclose filing an NDA. That research also disclosed that the time between the filing and the disclosure could be a few days to two months or more after the filing.
Data from 2010 thru 2016.
Of the 249 applications (188 NDAs and 61 BLAs), 222 (89.2%) were disclosed in at least 1 public medium (Figure), including in a press release for 196 applications (78.7%) (Table). Of the press releases, 196 (86.2%) were found on applicants’ websites. Of the applications, 157 (63.1%) were disclosed in SEC filings, including 136 (54.6%) in press releases and SEC filings. The overall rates of public disclosures increased from 87.5% in 2010 to 97.6% in 2016. Publicly traded companies were more likely to disclose applications in any medium compared with nonpublic companies (relative risk, 1.43; 95% CI, 1.09-1.90); private companies were less likely to disclose applications (relative risk, 0.70; 95% CI, 0.53-0.92) (Table). The median time to disclosure was 6 days (IQR, 1-63 days) for press releases, 55 days (IQR, 9-86 days) for SEC filings, and 6 days (IQR, 1-63 days) for any public media.