SAGE/MRNS—Rogerm, I partially agree with your post. SAGE will without a doubt be the first to market compared to MRNS and has the advantage of (higher) oral bioavailability. While MRNS’ current Magnolia trial is IV-based, oral activity has already been established in the CDKL5 study and MRNS will also be launching the Amaryllis study that uses oral Ganaxolone in PPD (if I were them I would restructure this into an MDD study). Now it will still be a larger pill/volume than SAGE’s due to the lower oral bioavailability, but will that matter to patients if MRNS competes with SAGE on pricing or marketing? Also Ganax’s half life is longer than Sage’s so theoretically at least, Ganax. should work as a once a day pill. Without a doubt, MRNS will need more time to run the trials and prove all this but with the right financial support or under the right ownership, things can speed up very fast. By the way, regarding pill size and frequency, Gabapentin (neurontin) for example doses 600mg 3 times a day and at its peak sales were $1B a year. I think the $10B depression market has room for more than one player.
For MRNS we can view PPD as just a means to get a readout at this point. We now know that for this class of drugs positive PPD predicts MDD thanks to SAGE. MDD is now the main target for both companies due to massive market opportunity. CCD-1042 (Ganaxolone) is already being tested in MDD by Mass General. With recent SAGE developments and a positive PPD for MRNS I would expect an MRNS-sponsored MDD trial immediately, perhaps with big pharma involvement. https://clinicaltrials.gov/ct2/show/NCT02900092?term=Ganaxolone&draw=2&rank=14
Lastly, oral Ganax has produced great results in CDKL5 compared to what is currently available. I wouldn’t say MRNS has nothing to show. I know you meant in PPD. Anyway, if this is the market perception, I would expect to see a big pop with the stock if the p2 data expected next quarter are positive. Regards.
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