Stock Watch: Summit’s Stock Plummets
Surprise Changes In The Middle Of A Phase III Study Are Probably Bad
What on earth would make a biotech company change the primary endpoint half way through a Phase III program and not discuss it with the FDA? There are at least two scenarios, neither of them good.
You may also be interested in...
Quarantines, travel restrictions and supply chain interruptions are likely to cause 'unavoidable protocol deviations' in ongoing clinical trials, FDA says in new guidance that encourages sponsors to consider whether alternative means for conducting safety assessments and collecting efficacy data should be implemented in light of the disruptions caused by the coronavirus.
Loss of exclusivity and other competitive pressures will continue to offset J&J’s pharmaceutical growth as its former blockbusters accumulate in ex-growth "other" categories. Can the pipeline take up the slack?
While the implications of the US Inflation Reduction Act are the focus of the sector’s concern this year, another regulatory development will impact earnings sooner.