First, it is what it is. We got banged with a CRL, and there is no way to spin it as "good news." I agree it is "good news" if indeed our technology was validated. But given the actions of the FDA was circumspect, I'm not fully convinced they wouldn't raise it as an issue in the future. If indeed it was validated through omission in a CRL, then I do think it good, albeit not address the immediate concern of SequestOx.
After thinking through both sides, IMO, the evidence that NH "knew" there was such an unsolvable problem, or was an issue that would sink the application does not fit with his actions. He was the one who was held back by his crew from buying the oxy/nal to be "ready to go." He lined up LPC assuming there would be a pop, and hence procure funding. I'm not going to read into the phone call "anger" tone, because that's purely subjective. But, it did cost him a bunch of cash (on paper), and in market cap. We are fortunate to be cash flow positive, and steadily increasing on the generic side, so to avoid collapse given a setback.
It seems nothing about this makes sense. Regular oxy seems to have a worse fed Tmax, Avridi no ability to sprinkle, and Embeda allowed to be sprinkled. If there exists a precedent for allowing sprinkling, and does so through labeling, it would seem this be allowed. To me, of all, it sounded like #2...we're going to have to do a fed/sprinkle BE, and be within limits.
In reality, someone with real pain will maybe sprinkle once, and then just realize easier to simply take before eating, rather than dosing through applesauce. The idea they are going to continually take pills until they feel something after they eat is absurd. We solve all the "abuse" potential, but are held back because we think people in pain, trying to use correctly, are too stupid to figure out the eating/pill relationship, and thus start gobbling pills fearing the first dose isn't working? Lol.
Flawed and wrong.
But, like it or not, it's our new reality.
And a new sp level it seems. This is where we were prior for 8 months prior to P3 results. They don't need a "conference call"--they need to get their butts in and meet face to face. Obtain as much written documentation as possible for what's needed. Clarity on the cost and plan of the one submission a month pledge. The only way forward with the ER's is confirmation that indeed the technology was validated--and that's what we need to find out.
Per the idea of "suing the company"--no grounds, not going to work or happen. The only ones to ever make any money in such suits are the lawyers anyway. If you lost 50 grand, you would be lucky to get back 1 or 2.
Now is SequestOx fixable with a side of Gerbers with instructions in English, Spanish, and Braille, or not, and does it validate our technology in a round-a-bout way? Those are two my biggest concerns for the moment.
Maz
"Beware of missing chances; otherwise it may be altogether too late some day" -- Franz Liszt
