I guess the longer it takes for the top line results to be released then initial optimism may diminish but lets analyze the current situation somewhat .
- Negative results (safety issues and/or patient health deterioration): If this was the situation PAA management would have been well aware and the MEND study would have been immediately stopped
- Bad results (safe but no patient benefit evident). My understanding is that the compassionate use extension for the existing 12 patients would not have been approved if there had been no evidence of a patient benefit. That would also have put a stop to the planned Phase/2/3 study.
I think its all fair for us to assume that if results were as in 1 and 2 then:
- PAA would not be seeking a pre-IND meeting, ODD, Phase 2/3 trial, new management hires, entered into a partnership with Berry consultants
- FightMND would not have requested PAA to apply for a further trial grant
So lets continue with the little analysis:
3. Average results (safe and minor benefits evident-MND progression slowed): In my opinion and as noted in the first bullet point above management, the board would be very wary of committing to such activities before the top line results are released. While the compassionate use programmed may have been approved committing to such activities (and funding) with very little hard evidence would be negligent or careless of management and the board. I also believe had the standard results been average the top line results would have been available and released much sooner than now
4. Overwhelmingly impressive (safe and major patient benefits-MND progression stabilized or reversed): Given all the recent events, FDA approach and ODD, additional management expertise, market information, investor hub responses, patient survival times, patient decision re extension of trialling, patient(s) joining the PAA SH list, results exceeding expectations is the most likely outcome. I would suggest that the lengthy timeframe for release of the top line results (as advised t the market) reflects the need to thoroughly check (re-check), interpret, peer review the results and to ensure the report accurately reflects the MEND study outcome. Too many people with "balls" on the line not to ensure complete and verifiable accuracy
In closing it would seem the SP (and volume) over the last couple of days is just a result of SH/investor exhaustion as they wait for the top line results to drop.
All just my own musings fr the PAA clique
(20min delay)