Relief Therapeutics Holding AG (RLFTF)

[Vanilla Fitbit]

PEGS...

No the inhaler form would not be automatically approved...
The IV version will be approved for EUA, and then NDA will be filed for full approval...

The inhaler as a new delivery system will still have to show efficiency and safety. The safety shouldn’t be any issue (efficiency shouldn’t either) but they have to get dosing correct and also efficiency with delivery directly into lungs...

The trial will run for MINIMUM os 288 patients.. (144 at home and 144 hospitalized).. now two things can change that...

#1. The DSMB could meet during the trial period and request early stop to request approval review because it is not ethical to still give placebo due to overwhelming efficiency... (this would be GREAT)

#2. As we (??) saw with the IV trial NRX/RT can add more patients (we still don’t know why they were added) which will delay results and add to that end 288 number.

I personally think the inhaler trial will enroll WAY WAY faster than IV.

The FDA is corrupt man... but once science is in the bag and available they can’t deny it