The webcast yesterday provided further information about the NP-1 results.
Last time Talley presented the top line data he said that the two extra weeks the treatment was prolonged from 4 to 6 weeks added a significant pain reduction compaired to placebo. Then I did the following reflextion: There are no medication in the market helping more than half of the patient group. In the trial versus PHN NP-1 acctually showed a result that 50% of the patients felt a 30% less pain score. Not far away. The new data in the presentation a week ago forced the market to review the whole paradigm: the two more weeks added, significantly more pain reduction so that starting a trial in the b r o a d diagnosis (15 million patients) was more than a probable outcome for the phase III trial design.
Now, what was the news from the Wall Street presentation, yesterday? Read carefully: The cream lessens pain for every extra week that is added seen from week 1-6! Talley shortly noted: I presume FDA wants an 8 weeks trial. (!) Acctually we do not know the slope of the curve, yet.
Meaning, Hey there!, the efficacy of Np-1 might exceed way beyond the half of the population. This is a tuff one, but nevertheless it must be stated:
+ NP-1 could be the outstanding best efficious medication in the diagnosis of perifer neuropathic pain. (Not just the one with no side-effects.)
We will have a deal on a phase III, but the magnitude of that deal is now to be review by the market the upcoming weeks.
Talley noted the reimbursement deal for Italy was closed. It sends an important signal. But, as I see it, every step towards the market for Ceplene supports the great extra value that a deal with a major on the phase III trial will give us. What upfronts to be achived? Two or three times the market cap? The milestones? Seen as a whole I now see Epicept as a pain Co, also having an attractive cancer portefolio.
Good luck to you all!
another question remains, how will they use the debt financing that is being announced. So the upfront for the next deal may be small, but not the milestones and royalties...
It's a patience game.
There is a debate in Sweden about when Ceplene will start to generate money. It should not be neccesary to take a loan for more than Epicept need, so to speak. I do not know the English word for it but when I have some of my real estates rebuiled I use a kind of facility that I can draw / use as long as I need it. Of course there is a maximum limit.The interest rate is a litle bit higher than the ordinary rate for the houses.
You are, anyways, right that for the moment the royalty for NP-1 is of more interest than the upfront. This is really a change in paradigm.
Yeah,you got it right in Swedish!
I have just been passing through Setubal some 15 years ago. A lot of pottery along the road in the center, if i remember correct. Stayed in Cadiz (Sp.) this fall. Nice!
Very nice news today. The focus on a 75% part of the patient group gives a more confident phase III. Let's see how many they acctually exclude from the trial. There are several paths here. The results will appear more evident thus the diffence between the treated group and the acctually not surviving group. I think this phase III will be monitored from an ethical point of view before it is finalized. Not giving people a medication that is relevant for others, and already approved in the EU, it is not possible for a longer time frame perspective. How many patient should be left without treatment and therefor die?
Will the excluded patient group recieve treatment from their prescribing physician when Ceplene is approved? - I think we will have a win-win for all here.
New patent adds value to the CO due to prolonged exclusivity.
It's very different now, totally urban even though most of the heavy industry has been abandoned. We're moving further to the countryside in a few months anyway, because virtually every city in Portugal is becoming infested with petty criminality due to several causes, among which unemployment must be the worse. There's still plenty of good, fresh seafood to have though...
I hope we see $2 dollars soon, and most important, an analyst upgrade with new target.
The next analysis on Epicept must consider the new paradigm for the CO, NP-1. There must be something to say before the ASCO-presentation...
Still remember the smoke from the grills in the Alfama blocks, Lissabon. The fishingboats catch herrings just outside my window on the Swedish westcoast every winter. But not this one, because of the ice sheet. It's not just the herrings surviving!
Ah, those neighborhoods are still very much the same! Most of the original tenants are gone but young people, mostly artists and scientists, live there now. Alfama, Madragoa, Bairro Alto and Mouraria, although uncontrolled immigration has been quite a problem since the late 1990s. To be frank I avoid the cities, everything is poorly organized and chaotic... except to the far inland where it is still possible to have both an urban and countryside lifestyle.