PSIVIDA startet durch !! (Seite 1000)
neuester Beitrag 27.11.15 13:39:44 von
pSivida’s Medidur™ Technology is a miniaturized, injectable, sustained-release drug delivery system designed to advance the treatment of medical conditions in critical areas such as ophthalmology, oncology and cardiology.
,” Myers said in a conference call with investment analysts. The company has asked for a meeting in the first week of February, he said, adding, “I’m very confident” the company can answer the FDA's questions then and get the approval process moving again"
hier nochmal die aussagen von bev,die auch bezug nehmen auf biosilicon/brachisyl!
Of the pSivida technologies:
Medidur (which is what underlies Iluvien) is being adaped as a
biodegradeable version - I believe some of that work is being done both
in-house at pSivida as well as with Pfizer (as it was the Medidur technology
that Pfizer licensed).
Durasert is sort of the same technology as Medidur, but far broader.
Again, I this also continues to be under development.
BioSilicon is definitely being developed and I think we may hear
something with regard to this early in 2011.
BrachySil is awaiting a partner - pSivida does not want to be the
one to take it through phase III trials as they would be extremely costly
and there are many, many companies involved in the pancreatic cancer
space....what pSivida hopes to do is partner or license this technology off
to a partner and let them do this.
Unfortunately the Pfizer contract is such that we absolutely cannot say
anything about Pfizer or what is going on. I have been told that we may
have something to report very soon....but until we do I really cannot
As to the 36 month trial data -- Alimera, who is the company that is in
charge of all clinical work and working with the FDA (even though we have
reference rights and co-ownership of all the data) was told by the FDA that
they will accept 24 month trial data for an NDA -- this is standard in the
industry - but the company must agree to provide the 36 month data. When
Alimera filed its NDA in June with the 24 month data we knew that the final
patient would complete the 36 month follow up in the following month of
October. So, all that 36-month follow up has been completed and the
statisticians are currently analyzing the data - so the 36 month data is not
quite as far away as people are assuming. I would think that the analysis
can be done relatively quickly (perhaps two to three months). I do not know
specifically what the FDA is looking for as complete response letters are
not public information. The good news in this, I believe, is that the FDA
did NOT request an additional trial - and that is a very big deal. I had
another client who got a CRL and in that one a trial was requested in order
to satisfy FDA questions.
So, here's the bottom line - we have a drug for which the FDA requires more
information before making a marketing decision. Alimera is the company that
will be talking with the FDA and carrying out whatever is necessary to
respond to the CRL. pSivida has $15M in the bank at the end of September;
its burn rate remains a very low $1.5M a QUARTER! So we have money and have
no need to raise money at the present time. We have an agreement with
Pfizer that has been moving along for the past three years - almost four now
-- so we would expect some news (and perhaps milestones) to be achieved in
2011. The company is talking with others regarding their technology
(remember Iluvien is actually relatively old at this point).
das hattest Du schon Mal reingestellt.
So `ne Partnersuche für Brachisyl dauert aber lange, finde ich.
Die Testreihe in England ist doch bestimmt schon 1 Jahr lang abgeschlossen, oder Kommt mir das nur so vor.
Hisichtlich Deinem "Reim" stimme ich Dir zu. Pfizer hat Medidur lizensiert.
Ergo wie Du gesagt hattest, die haben den Wirkstoff getestet. Nun wird Medidur der Träger sein.
Müssen die dann nicht auch noch beides zusammen als Phase 3 testen, d.h. bis zur Markteinführung bei Pfizer 3 - 4 Jahre. War doch bei Alim auch so.
Auf jeden Fall bleibt´s interessant, Spannung ist ja da.
Ich habe gelesen das Du segelst, habe dazu `ne Frage werde versuchen Dich privat anzumailen, diese Funktion soll es ja hier geben.
really say anything. I do know that all during this time they have been
working on many other of their technologies (not BrachySil, though as they
would prefer to license that out to a partner)....so we should see something
Ist schon da... Trading Halt wegen einer Capital raising Transaction.
Da bin ich ja mal gespannt.....
Was könnte das sein?
Da ich für Alimera keine Trading- Halt- Bekanntmachung finde, kann es nichts mit Illuvien und der FDA zu tun haben. Oder?
Mit welcher Transaction könnte man sein Kapital "aufhellen"?
Kapitalmaßnahmen, z.B. KE
Hoffendlich irre ich mich
Babelfish übersetzt das mit Kapitalaufnahmeverhandlung. Ich vermute mal es geht darum, dass sie einen Geldgeber gefunden haben, der die Phase 3 Trials von Brachysil finanziert.
Hoffentlich irre ich mich nicht......