Nice reply WeeZhul,
I am spending much less time on the board, for various reasons, and hence did not see your reply until this morning...on the ELTP bulletin board no less. Actually, would have waited given today was a news day, but feels this relates given the news.
Your response clearly pointed out differences in the pharmacokinetics which is an area much different than my own expertise, so will indeed defer to you on that point. But given today's news, (that I don't feel was "bad" at all), did, however, raise the specter that we had all seemed to discount: a total re-formulation of the oxy portion of the capsule bead. When the CRL was received, having to reformulate (as opposed to say sprinkle/applesauce etc) was almost universally viewed as the worst-case scenario by those commenting at the time; the hopes were for a quicker test(s) to measure and address the Tmax, not full reformulation.
Putting aside the ADF component in SOx, as the TMax issue was not due to naltrexone leakage, but to the issue of fat as a moderator of onset time, today's news is very telling is it not? That is: if our fatty-fed Tmax measure was acceptable as formulated, wouldn't the simplest/cheapest way to address be conducting one of the numerous variations of the aforementioned tests we discussed (and as currently done by others)? By taking the reformulation route, incurring more time and expense, appears as if the company knew the original fed Tmax was not up to the FDA acceptable standard (or found so in subsequent testing.) IMO, if they did know, they shouldn't have submitted in July (albeit the fatty food issue was ambiguous due to FDA change).
If unknown, wouldn't it seem they could have simply run an additional arm on this last study, under the rubric of comparing the Tmax's between the IR and ER for elucidating differences...but with the *real* purpose of simply getting a measurement of what the Tmax for fatty food was for the IR? If acceptable, subsequently use the results, as opposed to running a new series of tests--or re-formulating? The choice to reformulate was surely not taken lightly. Am I wrong--but couldn't the development of the hard-shell tablets been done concurrently with the IR reformulation, obviously with different speeds of dissolution?
But, as we see now, they quietly (probably to minimize further sell-off) chose to re-formulate, and as you have noted, likely have already, and initial (internal) results must have been good if they plan on forging out a new test so soon, and application thereafter. Whatever the R&D costs reformulation engendered, the fact it has already happened, save for the last round of test(s) and submission/resubmission. The only "bad" news is for those hoping to hit big in a few months time.
I am in agreement with your take on the application of Purdue's patent limitations, and how we stand in a great position to capitalize on that. The newer oxy generic must be in part the amount alluded to by NH in the last CC about the profitability of coming ones this year. That alone could be huge. If your timeline is correct, we could be looking a 1-2 punch, between the generic oxy hitting the market closely followed by the IR approval. Just need to wait just a little longer--as is the case in about every biotech I have ever owned--just goes with the nature of the beast. Not thrilled it didn't go faster, but I do see a clear path to money in the cards.
Your clarification and correction much appreciated. Back to obsecurity. Way too easy to get caught up in the non-drama of the daily sp. My very best to you,
Maz
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