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Immune Pharmaceuticals, Inc. Message Board

  • larshansson18 larshansson18 May 9, 2010 1:49 PM Flag

    Basic reason

    for the downturn last week in Epicept might be the rejected FDA application for the substance Perfenidone (Intermune).

    There was a request for another confirmatory trial from FDA in this case. The market took out all it had in these Greece times. Epicept is about to applicate to the FDA having one phase III trial.

    Investors who wants to take an own stand here, look at this:

    The trails for the medicine in question shows some more weeks of prolonged life and sertain grade of change in quality of life. But, patients do not survive because of the threapy. One trial showed unsignificant results and another showed significant dito.

    Ceplene do not have the side effect the above medicine acctually have and - many patients acctually survive because of Ceplene. Some 46 % of the total group and some 75% of the younger patients. Given an outcome of less than 20% using standard of care in the total group.

    Managements point in the three last webcasts is that the results are roboust and N (number of patients in the trial) is relatively high given it is a rare disease. Also comparable medicines have got approval having the same back-ground as the Ceplene application do have. Please, relisten to that part of the latest webcasts discussing the fact that there is just one phase III trial.

    There was an ODAC meeting last fall giving new, more clear, guidance on these issues. That meeting is the mother of sources for those who wants to do there own DD about the robustness of Epicepts application to the FDA for Ceplene on the US market.


    There are several ways of financing Epicept.

    There are no signs of a quick fix from management:

    + It is silent around the ASAP-technology. It seems to be for sale when it have shown proof of concept. Spelling A--x-.

    + NP-1. Management waits, as it seems up to this date, for the phase IIb trail to end up this summer given them the opportunity to use the preliminary results direct to the interested CO's. I figure management knows why they find the results worth waiting for. Don't forget: the potential patients for PHN is 200 000 per annum in the US, and the market for the diagnosis of pain in cancer is 4-5 million patients. No competing therapies in that diagnosis.

    + Ceplene. The NDA will be handed over to the FDA some time in June. The fact that Epicepts management have handed over the information concerning the progress of sales of Ceplene to Meda is interesting for those of us having the opinion that there already is a solution of the,forseen, cash problem that would come in Q3.

    Last summer we had a finacing, priced o v e r the current share price ($2.4), 7% dilution it was. R&R fixed the deal after the breakdown of the Ceplene-deal. Will there be a small, temporary 5%-dilution or a bigger structural solution?

    I think we will have a bigger "Swedish" solution. A solution already decided long ago.

    Some people here just bark. Hope the rest of you have some liquidity threse days. Historically it seems to be an opportunity right now out there!

    Have a nice week-end!


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