First, he essentially mirrors the conclusions that I have been putting forth for MONTHS.
Primarily,it is that ceplene will not be a big time drug, but only a modest one, contrary to what management has lead investors to believe.
The one HUGE thing in the article (that no one has yet mentioned) is that we now have Talley for the first time CONCEDING that fact in a public statement.
He has for a few years now talked about the market opportunity as being in the US and EU (and we can assume that a partner would tie up both sides of the Atlantic) of 300 MILLION PER YEAR.
BUT! in his discussion with Adam, he divulges that ceplene wasn't big enough for the supposed prospective partner. See the problem here?
1 - 300 million (even 150 mill, if you want to only count the EU for now) IS big by any measure for ANY pharma of ANY size. Especially given the dearth of products, patent issues. etc. ALL big pharmas have drugs in their portfolios MUCH MUCH smaller than 150 million!
2 - He also admitted that that prospective partner made that determination AT THE CONTRACT TERMS point in time. WOW! Well, that tells us that only AFTER their due diligence did they uncover what I've said all along: it won't command that great a return thereby confirming the fact that he has oversold ceplene's potential all along.
I find it peculiar to say the least that Talley didn't find it necessary to divulge EITHER of these two critical facts to investors. Why is he conceding them now? That's the natural question to ask.
4 - The reason he put that info out there now is that he is prepping the marketplace for disappointment once the deal term are finally announced.
The reality is that the terms of the deal when and if announced, will be VERY under-whelming. (As I have said for months.)
I wouldn't expect Adam to be as up on EPCT as I am thus I am not surprised that he didn't delve into with Talley the other two main issues, which are pricing and IDIS sales, both of which will likely be disappointments.
Not only is 150 mill big enough, but for just about any established pharma, ceplene SHOULD be a straight forward add-on to their existing oncology marketing, distribution, and sales force.
So, his story makes no sense on multiple grounds.
Either the pharma told him the size issue as a convenient "out", or he is leaving something out. Probably a mix of both. I still think that it has to do with reimbursement.
I am going to conjecture that the partner may have seen that there would be issues with getting the reimbursement approved at a respectable rate, and balked at not only the hassle of that obstacle, but also they saw that that rate would likely be no where near premium level even if approved.
This explanation would explain his very telling omissions of any substantive commentary having to do with reimbursement activities. In fact, he's said next to nothing on the topic which is odd given that we are ONE YEAR post approval.
Oh! And he also confirmed another point i have said all along:
And that is that the ceplene vs il2 alone issue is far from being "concluded" as Talley says. Adam agreed in his article that just because the EU let that issue go, in NO WAY means the FDA will.
I'll go even further and say that I am fairly certain that the FDA will not let the issue slide by.
Recently, Talley has taken to bantering about in his presentations some statistic about the FDA approval rate when the EMEA has already approved a candidate as being 80%. Therefore, ceplene "has at least" that great a chance, he say.
BALONEY! For him to try to oversimplify the odds of FDA approval by quoting that single over-arching statistic is just plain CRAP and he knows it. It is so much more complicated than that, that his putting it in such terms is just plain irresponsible. Its just more smoke and mirrors.
Jonaustin, principally I like your thoughtful speculations, however in the the case of ceplene vs. IL-3 alone you are medically wrong and your FDA speculation is apodictic. There is evidence and I told you that already in the past.
I’m not suspicious of being a friend of this EPCT crap mgmt, and though I agree that Talley is less than recognized in the pharma scene, also a couple of managers in major pharma companies are not capable to identify a market opportunity. Time will show that.
topaz, you point is a fair one, and in an otherwise normal world, I would perhaps be tempted to acquiesce to it, but we're talking about EPCT here, so let me explain.
You are correct that there exists some evidence that il2 has no therapeutic benefit, but the problem is that that data is piecemeal and the mechanistic explanation of both il2+ ceplene is hypothetical, perhaps a very rational hypothesis, but a hypothesis nonetheless. And the il2 alone data is all separate from any ceplene studies, IOW its not a head to head comparison in a multi arm study..
There are a few reasons why a head to head trial is necessary. One is because although no standalone evidence of il2 benefit in AML, the obvious question is whether there is ANY contribution to the effect of ceplene in a clinical setting and what is its magnitude, hence almost like a placebo-like contribution to the statistical significance of ceplene that must be backed out.
The reason this is important is that, relative to the EMEA, the FDA is by far much more so sticklers for statistical rigor without question and they are rue to accept piecemeal data to explain away an obvious question that SHOULD have been designed into the original studies as a separate arm.
Further, the FDA has a long memory. They will inevitably raise the issue that in its original submission by maxim for melanoma, that there WAS an il2 alone arm, and guess what, it DID contribute to the ceplene benefit, and when backed out, was great enough to knock out ceplene's stat sig. Ultimately, the NDA was rejected on that basis for that indication.
Which raises an obvious question: Knowing this, why did the subsequent AML studies omit such an arm?
Having said all of that, and given the orphan nature of AML, it may be that they do let the issue slide (but I doubt it) BUT, at a minimum, they will require a post approval trial. This would be an accelerated approval in essence, but its a long shot, because their attitude will likely be "you've been aware of this issue for years, why havent you already initiated such studies . . .?"