The company held a webcast yesterday. Here is a summary of what was new, in the order they were presented: (Using a quickly improved Google translation from Swedish.)
1st In Italy, there was another insured price 43 500 USD for an entire treatment. Same as the market price in Germany. Talley was pleased.
2nd What remains of the SPA-negotiation is to determine the facts under which the study is interrupted prematurely. A meeting with leading U.S. hematologists and statistics later this month will provide guidance on this. There will be an interim analysis of a so-called DSMB committee that is studying whether it is ethical to continue the trial, given some predetermined outcome.
3rd Fast Track application is related to point 2.
4th The design of the new study has four new features:
+ Epicept want patients to have undergone at least one consolidation treatment with chemo before Ceplene cure starts.
+ Ceplene is more effective the earlier the treatment starts, therefore, want they want to start the cure no later than 1 month run at remission (less than 5% cancer cells in the blood). In the previous study, it was expected up to 6 months after going into remission.
+ Ceplene seems best at the patients who received their first relief from the cancer cells. It will not bring in those who are in a later phase of the disease, in a second or third remission.
+ It allows standard of care include what the local doctor choice gives of other options.
Here Talley reiterated the points made earlier, but now with a stronger and more colorful language:
The study was a "breakthrough" in terms of efficiency for the cream.
The number of patients who were treated with pain associated with Taxan was more than 2 million, of which 1 million were breast cancer patients.
The FDA wants to to have between 8-12 week treatment of various forms of neuropathic pain for the phase III trial design. In this context, Talley saw the significant result that NP-1 was more effective for each new week treatment progressed as important to fully grasp.
" Ceplene is more effective the earlier the treatment starts, therefore, want they want to start the cure no later than 1 month run at remission (less than 5% cancer cells in the blood). In the previous study, it was expected up to 6 months after going into remission."
You do not understand Swedish? "Kur" and "behandling" is about the same. Didn't notice that Google translation: Cure should be/mean "treatment".
The webcast can be find at www.epicept.com
Here you can practice some Swedish:
"Gruvgunnar 11-03-10 19:13:58 Anmäl inlägget
Bolaget höll en webcast igår. Här är en sammanfattning av det som var nytt, i den ordning det presenterades:
1. I Italien blev det återförsäkrade priset 43 500 USD för en hel behandling. Samma som marknadspriset i Tyskland. Talley var nöjd.
2. Det som återstår av SPA-förhandlingar är att bestämma de faktiska omständigheterna under vilka hela studien bryts i förtid. Ett möte med ledande US hematologer och statistiker senare denna månad skall ge guidance för detta. Man kommer begära en interimistiskt analys av en s k DSMB-kommitté som studerar om det är etiskt försvarbart att fortsätta studien givet vissa förutbestämda utfall.
3. Fast track-ansökan är knuten till punkt 2.
4. Designen av den nya studien har fyra nyheter:
+ Man vill att patienterna skall ha genomgått minst en konsolideringsbehandling med kemo innan Ceplene-kuren startar.
+ Ceplene blir effektivare ju tidigare behandlingen sätts in, därför vill man starta senast 1 månad efter remission upnåtts (färre än 5% cancerceller i blodet). I förra studien väntade man upp mot 6 månader.
+ Ceplene verkar bäst på de patienter som fått sin första befrielse från cancercellerna. Man kommer inte att ta in de som är i en senare fas av sjukdomen, i en andra eller tredje remission.
+ Man låter standard of care innefatta vad den lokala läkaren väljer för annat alternativ.
Här upprepade Talley det som sagts tidigare, men nu med starkare och mer målande språk:
Studien var en ”breakthrough” vad gäller krämens effektivitet.
Antalet patienter som vårdades med smärta i samband med Taxan var drygt 2 miljoner, varav 1 milj var bröstcancerpatienter.
FDA vill i fas III ha mellan 8-12 veckor lång behandling i olika former av neuropatisk smärta. I detta sammanhang såg Talley det signifikanta resultatet att NP-1 var mer effektivt för varje ny vecka behandlingen fortskred som viktigt att förstå vidden av.
National cancer institute, NCI, har lämnat in sin rapport till sommarens ASCO. Det innebär att vi kan läsa abstracten senare i vår.
Azixa kommer att redovisas på ASCO och Crinobulin redovisas i slutet av året."
The webcast summary is relevant, as is your note about share price.
I think that the major turn around was in december. The acctual path of the continuation of the turn around I do not know. I have decided to put in money and stay long for the two years to come. Maybe the movements will look like the december eruption? There are many people having just the same question as you have. So I think that "eruption type" will be the first couple of 100 %'s. When confidence is back, maybe we have another kind of path. My choice is this: move upward is bigger then the effect of any delution in the future. That holds especially during the spring -11.
Shorter?, look out for the shorters activity here, with some human delay. :-) But you may miss the big news/moves that way. I understood that most of the active shorters missed the december move, after all their negative work on different threads. New strategies coming up now? Think so. If they meet in real life, do they have one vote per capita or per signature?
You are an ignorant moron.
The share price reflects its being adrift with no news while daytraders and small holders, like you, sell or short it. The core holders of this stock are still here, and smart money does not move earlier than it needs to while there is profit to make faster elsewhere.
Appreciate your input you know more about this comapny than some officers working for epct..THKS..I know some of you on this board have been here a long time and at least in a few yrs some here will get rewarded and actually some here will get rewarded this yr depending on where shares were bought...thks and good luck.....Maybe I am the dumb one here thinking this comapny one day will deliver...cheers