RedHill Biopharma Ltd (RDHL)

[Amatuer17]

Don’t shoot the messenger - from the PR - read 3 para below

“The regulatory path for opaganib, including potential submissions of emergency use applications in those countries, is subject to whether the data generated by the ongoing Phase 2/3 study is sufficiently positive and supportive, as well as the specific requirements in each country.

Additional studies to support the potential of such applications and the use or marketing of opaganib are likely to be required.

For example, the FDA has indicated we will need to complete additional studies to support applications in the U.S. The strength of the safety and efficacy data generated from the opaganib studies will be key to regulatory applications. Evaluations and discussions continue with the FDA, EMA and regulators in other countries.”