I will explain why the company didn't provide the data in the PR or at least a link to it below, but with a little work, I found it, here it is:
It is good data, but just updated data, nothing new and certainly not a game changer.
And that is the precise reason the PR just touted it as a release of "new" data and only gave the p values. That was a strategic maneuver, because its not really new and they are aware that the detractors will continue to point out two things:
1 - The control was "no treatment." People want to see the curves for ceplene/IL2 vs IL2 alone.
2 - The study, though it ended in 2004, has few subjects such that it is low powered, and five years later still has yet to demonstrate achievement of stat sig of the secondary OS endpoint. (Currently stands at p=0.33)
In my opinion, I believe the FDA will want to see a full trial demonstrating that the C/IL2 vs IL2 effect. I'm speculating, but this unacknowledged fact may explain the need for additional funds probably even above whatever upfront payment a ceplene partner would ostensibly provide.
On the positive side, there is a significant unmet need in AML remission therapy, thus LFS alone may be sufficient for the FDA, because in normal cases, OS is the usual gold standard.
Nonetheless, though Dr Hellstrand gave an outstanding and plausible mechanistic explanation of the C/IL2 vs IL2 alone dynamic, I believe it will need a more thorough clinical demonstration.
I will continue to hold a meager position and again will withhold further comment until management provides more information.
Nice analysis and I always like to take the time to respond when people take the time to offer up well reasoned information.
I don't completely disagree about the potential of the pipeline, there is certainly value there, however, I am not yet quite as sanguine as you. Let me balance out your optimism by adding a few comments, except on ceplene, since enough has and is being said there:
1 - Azixa is a big unknown until new data is available. You say its going into PIII this year, but we are far from knowing that. I have tried to find some new data but can't and MYGN is very strangely silent on the matter. I was also a bit surprised that there wasn't at least a poster at ASCO with at least some rehashed old data just to promote the drug, but nothing. I fear it may be a casualty in the MYGN reorganization. So without addt'l info I can't make an investment decision based on that alone.
2 - I have a hard time, frankly, evaluating NP1 because its really outside what I usually invest in, so I don't really know much about it. It would take 10 hours or so of research for me to put any kind of value on it, and I was waiting to do that after a ceplene partner, since NP1 would have been the next catalyst in line. I will say this though: I believe it has a very long nebulous history, which is always a big red flag in general for me, because "blockbusters" don't sit idle and unpartnered for quite so long. But overall, I reserve judgement for now.
3 - Crinobulin: For me, Phase I data is meaningless, I just don't trade or invest based on it. Phase I is a necessary step, yes, but for an investor the information is very limited in value. When's the last time you saw bad PI data? It's always good! This rule has a few exceptions where phase I really means something, but never in oncology. Virochem's HCV drug that got scooped up by VRTX, comes to mind.
So, I (and apparently the bulk of the market) care about two things: 1 - cash, and 2 - ceplene
There is unprecedented value in their pipeline, I think we made a bad deal with Myriad and Azixa, Myriad has also been taking a lot of time with their Azixa trials.
This pipeline was asssembled or acquired by this management team, and they have cut expenses, closing R&D and focussing on what they already have. To me, the team has done pretty good - nobody would be excited about anything in here if not for this management - it's painful for people to read that, in light of the dilutions, and grants mostly the compensatory grants - at the end of the day, I like this management.
If the proverbial thumb was placed where it didn't belong all day, I feel strongly Epct would not be publicly held today.
Been reading about Hemispherx Biopharma, and I do not want to compare EPCT with that company. I first discovered EPCT july last year, at 1,75 sek (usd 0,35) before Ceplene-approval.
Searching for the solution of my bad portfolio, minus 25% I started evaluate the potential of EPCT (among other companies)and the chance to get an approval for Ceplene, reading articles, analyst report and actually took the opportunity to speak with the inventor of Ceplene, K.Hellstrand, and made my decision to put at least 20% of portfolio in Epicept. The dedication and knowledge of K.Hellstrand made the decision easy.
I agree that the management is a self-serving-management, takes all the chances they can get to reward themselves. It's like they are living in the dot.com-bubble and money will never be a problem. Now they got a hint, that we dont like that kind of management. In hard times it's important to lower the costs, and to be a good example yourself. Thats what we in sweden like.
An american saying I like is "treat your employee as he could be your boss" and you will not get any problem in the future. In our situation it would be, "treat the shareholders as if they are the boss" and thats also a fact! We own this company and they are paid by us! now they are aware of that fact.
Besides the management there are in fact values that should be of interest of any investor that EPCT management hardly can destroy. Azixa, Myriad pharmaceuticals most valuable drug (starting Ph.III later this year) for the spin-off with a market worht 7 B.usd for USA+EU alone, EP-1013 in collaboration with GNI that should already start PhaseII this year, http://investor.epicept.com/releasedetail.cfm?ReleaseID=322691.
Then we have Ceplene, which in EU alone at only 15% royalty and upfront 50 M.usd is by analyst valued to 200 B.usd. (note that ceplene has 10 year exclusivity in EU.)
Further on we have Crinobulin and NP-1. NP-1 that also has a "blockbuster"-potential. Another analyst on http://www.epvantage.com/ (search for Epicept) valuate the pipeline to 633 Musd, without Azixa!
We are not just small private investors spending time into forum like this. I cannot afford investments like this without thourough research.
Have a nice weekend!
Hey, good luck with fried chicken guy!
If you have any hot stock tips, let someone know, okay? But do it by word of mouth because otherwise you will continue to cast pearls among swine. Follow your instincts and keep it to yourself, as per the implicature of your message.
Just a suggestion.
As in the Ol' good cop, bad cop routine?
What purpose would that serve?
Just so that people know, I thrive on discord. I WANT people to disagree with me, refute my points, offer substantive debate. It is through that process an objective investor can arrive a conclusion.
And, truth is, fried chicken guy is the only one here who makes the effort to present an opposing view.
I think the average EPCT investor is just a small fry who has only a small amount of money in it, so they have a "que sera sera" attitude, which is fine, not the way to make money, but fine.
I do not have the pleasure of knowing Mr. Austin personally, only through the back and forth here, essentially I believe we have some opposing views, but I appreciate his sort of input, he's not bashing posters in here, but he puts together thought provoking arguments, I try my best to do that as well, I think that makes for a better message board....any way...good luck all.
I agree that this is a PR strategy, however, I like that they are putting out a PR strategy, lots of news this week, I hope the news keeps coming regardless. Before, people were criticizing for no PR, adding to the sentiment of Epicept being an unknown company.
Keep the PR coming JT!!!
That, frankly, is a very very foolish mindset.
The reason is, that more often than not, in the biotech realm, PR blitzes should raise one's eyebrows and sense of caution, but more than likely it means that management is seeking to divert attention and/or prime the market for bad news, not good.
That is exactly what is happening here and its obvious given the "partner" PR (when there was no "real" partner) and then the "new data" PR (when the omitted the data intentionally to divert attention).
Here is a very recent example: Adam F. this morning writes about many of the same questions I ask about EPCT but in the context of HEB.
Different companies, same smoke and mirrors approach PR. Whenever you see such tactics, as an investor, it should arouse your sense of caution at the least.
It pays to be cynical. ALWAYS!