Elite Pharmaceuticals Inc (ELTP)

[Dante Fantasia]

What one has to consider in looking at that data is: If the new formulation w/o naltrexone, which looks the best on the face of it from this small sample, going to require another, separate filing and thus engender submission costs? One cannot simply call the new formulation "SequestOx" simply because it's the same company submitting an ADF. This is a question as I do not claim to know--but an important one.

Then, there's the consideration: What happens with the Epic deal if they submit this instead?

Remember per the last set of financials, it was stated that it will materially and negatively affect ELTP if they do not end up getting the 7.5mm milestone from Epic. Could submitting an entirely new formulation negate the deal? Epic may or may not want an excuse out, and this could potentially give them the leeway if they do.

Also, to get the free FDA filing fee waiver for the 3rd round submission, it has to be in by end of December. That means ELTP better be quick in testing, and then meeting and re-filing with the FDA. They better be close to doing a BE now or shortly.

No new patent on the new formulation? I am surprised they don't have one if it really is that good...though would suspect that because they have been able to keep it to themselves, no need to disclose at this point, so that may not be an issue at all. Still, I would have still expected to see a patent at this point to ensure ownership exclusivity. They had to get clearance to test on human subjects by the FDA, so if BP is in bed with them, need to make sure that there are no "leaks" besides the pill itself w/o patent.

GLTA,

Maz