As you perhaps already know, this is not the diagnosis that Ceplene is working against. See for example the list of potential patients in the US in the last webcast. Look at the last slides where the transplanted patient is moved away as potential patients. (They constitutes some 20% of all patients.)
("The authors of the paper conclude, “…immunotherapy in combination with primed lymphocytes and autologous stem cell transplantation shows encouraging signals of potential activity in acute myeloid leukemia.”")
The more patient that recieve first remission, the more patient have a potential demand for a cure versus relaps from that paus from the cancer. That use to be the most common answer to new treatment for AML.
When do the new 12 year legislation start to be the prevailing law? Direct after the signing? Anyone, please.
Yes, you are right and I did know that. This treatment looks like an improved way to reach full remission but relapses occur eventually, as with other treatments. Those patients in full remission who want to delay remission could still be served by Ceplene. A question is, how many patients will relapse? At the moment, it is most. If this treatment reduced eventual relapse per se, it could reduce the perceived need for ceplene. But this seems unlikely.
Given the outcome that Ceplene takes a huge part of the patients reaching full remission, how would you perform a clinical test where you investigate the explained variance of Ceplene versus new better treatments going into remission? A control group not taking Ceplene?
Let's hope for more new treatments that do have less side effects and efficacy. Ceplene will have the 10 year exclusivity in the EU and 7 years in USA.
I have understood that the new legislation is to protect against generica, not new kind of treatments. So the patent protection for Ceplene equals the new legislation here. But Np-1 seems to be taken some years of benefit with the new legislation.
There have been some notice around the exceeding of label sales of Lidoderm in Sweden. The predicted, total, market is 450 milllion USD and Lidoderm is selling for some 700+.....
Seems like the of label sales is of significans here if you would like to understand the value of NP-1. The 500-1000 prediction for NP-1 seems NOT to be an overestimate. The essens here is the lack of side effects combind with efficacy.