Antwort auf Beitrag Nr.:
40.808.203 von Peter_02 am 06.01.11
hier nochmal die aussagen von bev,die auch bezug nehmen auf
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
in-house at pSivida as well as with Pfizer (as it was the Medidur
that Pfizer licensed).
Durasert is sort of the same technology as Medidur, but far
Again, I this also continues to be under development.
BioSilicon is definitely being developed and I think we may
something with regard to this early in 2011.
BrachySil is awaiting a partner - pSivida does not want to be
one to take it through phase III trials as they would be extremely
and there are many, many companies involved in the pancreatic
space....what pSivida hopes to do is partner or license this
to a partner and let them do this.
Unfortunately the Pfizer contract is such that we absolutely cannot
anything about Pfizer or what is going on. I have been told that we
have something to report very soon....but until we do I really
As to the 36 month trial data -- Alimera, who is the company that
charge of all clinical work and working with the FDA (even though
reference rights and co-ownership of all the data) was told by the
they will accept 24 month trial data for an NDA -- this is standard
industry - but the company must agree to provide the 36 month data.
Alimera filed its NDA in June with the 24 month data we knew that
patient would complete the 36 month follow up in the following
October. So, all that 36-month follow up has been completed and
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
can be done relatively quickly (perhaps two to three months). I do
specifically what the FDA is looking for as complete response
not public information. The good news in this, I believe, is that
did NOT request an additional trial - and that is a very big deal.
another client who got a CRL and in that one a trial was requested
to satisfy FDA questions.
So, here's the bottom line - we have a drug for which the FDA
information before making a marketing decision. Alimera is the
will be talking with the FDA and carrying out whatever is necessary
respond to the CRL. pSivida has $15M in the bank at the end of
its burn rate remains a very low $1.5M a QUARTER! So we have money
no need to raise money at the present time. We have an agreement
Pfizer that has been moving along for the past three years - almost
-- so we would expect some news (and perhaps milestones) to be
2011. The company is talking with others regarding their
(remember Iluvien is actually relatively old at this point).