$SPHS thoughts (vs $NYMX)
So I would first say that I am long $SPHS and possibly biased. Take these comments with that in mind.
I think it is very unlikely that $NYMX will be able to file for an NDA in the US, because the initial P3 trials they did failed. However, the did report successful extension trial results. I think the broader retail market assumes that they will be able to get FDA approval based on just the $NYMX extension trial, but I think that is false.
I highly doubt (and this is just my opinion) that $NYMX can get approval with 2 failed P3 trials and one extension that was succcessful. I would love to see if someone could point out to me a case where the FDA approved based on that.
So, that being said, I think that is pressuring $SPHS in that retail is staying away from $SPHS currently because they think $NYMX is so far ahead. Further, I think they are staying away because they think $SPHS's P3 trial is going to fail.
I am not sure when the FDA will get back to $NYMX on if they can file in the US for approval based on only one extension trial. However, I think if the FDA denies that option, the PPS is going to absolutely crater. That being said, I think it is in $NYMX's interest to drag out the conversation as long as possible with the FDA, because prolonging the news is better than immediately reporting the FDA isn't going to let them file an NDA based on one extension trial.
If the FDA denies $NYMX, then $SPHS would also spike up tremendously as the main competition would be significantly delayed, and IMO, $SPHS would be back in the lead (in the race to file an NDA in the US).
It will be interesting to see what happens when the FDA gets back to $NYMX about filing for an NDA based on just an extension trial.
g
