I guess the secondary target my be passed, the El Gueara-formation. But the main target is left to be tested.
Have a look in the last presentation at the flower-stylestructure of the main target.. You find the presentation on the CO's homepage.
Jag tog några aktieridag och hoppade överefterrätten. :-) Mot mina principer att ligga över borrning, men vädret är fint och livet leker så varför inte i Tunisien också? Kanske?
There are also two interviews on the same site, Onemedplace ("database"). The one from July 27 is interesting if you want to know more about the way of action and the commersial way forward for the Immune pipeline.
Our new CEO also lines out the present values for similar CO.
My post that I wrote som 40 min ago seems to be gone, so:
Watch the new presentation on the new CO:
Watch out for this one concerning the potential concerning Amket, after 9 min 40 sec:
"Immune och Epicept is commited to continue partnering discussions and initiate the phase III trial in 2013."
Also note there is a preclinical out licencing under way 2013.
Interesting comparisson to competitors for the new drugs from Immune.
Again, are you just showing your own capacity of realizing value, midswe?
They are selling a possible annual sales of 4-500 MUSD on each of the US and EU market.
Have you noticed that Epicept will take Myrx to the court, look at the Q-report. Myrx will have to decide themselfs if it is worth the fight or if they should join Epicept/Amiket when the possibillity to beat them seem not to good. An understatement?
MYRX have appr 90 MUSD in cash. Open for a transition.
After todays news the Ceplene rights is fully in the hands of Epicept, but a geographical part (The EU and RIM-countries) and the production for these markets and the costs for the post approval study in the EU now is taken by Meda.
Their is a more specified patientgroup for Ceplene after the latest results from Thorén et al (www.Pubmed.com)
I wait for some initiatives from management concerning KOLs and the pathway forward for a new trial design in the US for Ceplene.
No PP, but new deals seems to be next step. The Edison report is reasonable.
Ceplene is medicaly interesting for use in another diagnosis. Do not think that will be medically different 6 month later.
"Together, these observations support the rationale for restoration of normal NK cell functions in patients with CLL, putatively through the use of immune therapy protocols that already have demonstrated some benefit in acute myeloid leukaemia such as interleukin-2 plus histamine dihydrochloride."
Published online January 2012.
We have a value driver here.
"SATELLITE SYMPOSIUM SUPPORTED BY MEDA PHARMA
16:15 – 18:15 Emerald Room
LEUKEMIA-RELATED IMMUNOSUPPRESSION - MECHANISMS
Chair: J Rowe (FACP, Haifa, Israel)
Co-Chairman: G Ossenkoppele (University Medical Center, Amsterdam,
16:15 – 16:20
J Rowe (FACP, Haifa, Israel)
16:20 – 16:50
Mechanisms of immunosurveillance and implications for treatment
J Greiner (University of Ulm, Ulm, Germany)
16:50 – 17:20
Clinical data on Ceplene
G Ossenkoppele (University Medical Center, Amsterdam, The Netherlands)
17:20 – 17:50
New data on Ceplene
F Bergh Thorén (University of Gothenburg, Gothenburg, Sweden)
17:50 – 18:00
J Rowe (FACP, Haifa, Israel)
18:00 – 18:15
Annual meeting for the European Hematologists
http://www.ehaweb.org/assets/Congress/EHA17-Satellite-Symposia-Booklet-FINAL.pdf Page 33.
Please, read Epicepts releases to have a perspective on the question of the medical and therefor juridical relevance of further studies in Azixa from the given results up til now.
It's all about significanse and proof of concept.
Azixa? Epicept have the obvious possibility to sue Myrx if they do not develope Azixa if there is a medical potential for that( the, until now, several ongoing phase II in different brain cancer diagnosis).
The treaty might make the statement "Myrx cash is Epicept's", worth a thought.
Have a look at "11.3 Dispute Resolution" ("...punitive damages. Any award rendered in such arbitration may be enforced by either party in the state or federal courts located in either the State of Utah or the State of California."
Also check the latest releases from Epicept.
Sales acctually started in January.
I think we have a strategic struggel between Meda and Epicept, the one who affords waiting wins, so to speak.
The results from the post-approval study out later this spring? One of the cards to be played. A factorial trial without M2 will be a success, I think. Sell the US market to another CO.
Amiket gives Ceplene a new context, no need for a rush here (that is from Epicepts perspectiv. Patients perspectiv, hm.)
Epicepts management wants bid on the whole CO. The process should be ready Mars/April and finalized in early summer.
Talley thinks that a US buyer is more likely than a european dito.
Good Luck to you all.
Now we can understand why Epicept wanted a mutually approved minutes from the FDA meeting in December on the design of phase III study of Amiket:
Firstly, the minutes/FDA offered Epicept to make one (1) study before approving the NDA. It shortens the process and make it less expensive, of course.
Secondly, the sensational, which took me by total surprise:
"An Additional two-arm efficacy study in another Painful Peripheral Neuropathy May Be Performed as an alternative strategy to a second factorial-designed trial for the NDA filing, Which Could Potentially Lead to a broad label in the treatment of peripheral neuropathic pain."
The confirmatory follow-up study,
+ will be two armed, Amiket versus placebo for 12 weeks!
+ And , the sensational part, the trial may, according to the protocol, target the broad 15 million patients diagnosis if it chooses to go for that target!
I guess we will upda have updates from several of the financial actors on this turn-around development.
Good luck, everyone.
Look at the trial design for Amiket. The confirmatory design to be discussed! Probably meaning that it could be one but maube a four arm trial. Again.
Epicept saves time to approval. One trial costs 16 MUSD. Great news!!
NCI have performed a phase IIb trial having 461 participants using Amiket.
The results seems to be excellent? P-value 0,001.
A third part evaluation of the economic outcome from the future Amiket market - in the US alone - seems more than interesting? 400 MUSD per annum. Epicept will seek approval in the EU as well.
We are now waiting for the minutes from the end-of -phase 2-meeting that the representaives have named a "succes" as for the design of the phase III that will start late Q2. After that Epicept will negotiate a SPA for Amikets phase III trial.