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Biotech / Medical : PSDV - pSivida Limited -- Ignore unavailable to you. Want to Upgrade?


To: Arthur Radley who wrote (198)9/29/2009 1:13:21 PM
From: John McCarthy  Respond to of 421
 
Arthur

Am I misinterpreting the data? It appears the low dosage is pretty low efficacy, whereas the high dose causes problems.

IMO - not at all.

I've dumbed it down to this:

a) 12 months is the sweet spot - BUT - I am saying this
based on 37 people ... which means I ain't saying anything ..

b) I was UPSET at the low dose efficacy with respect to
both 15 line and 10 line. It (appears) to have fallen
off the cliff vs 12 months (and we don't have 10 line
12 month data so I am inferring)

Now what?

I can take Sushi $$$ off the table (for wife and son (I hate it)) and give it to the taxman ..... or

continue playing THIS TABLE - but the table is (FEELS) cold.

This is YOUR fault and KENS fault. -g-

Nice old me just wanted to play and you guys had to go and get
scientific and Einstein_ish with FACTS.

Worse:

I ain't buying Lucentis 1 bit. It works. But their trying
to buy ALL their employess a new MERC with just ITS revenues.

i.e $2,000/month times 5 years = $120,000 NUTS
(and I really think its $2,600/month but ain't gonna
quibble)

Can't find SOLID FIGURES for IMPROVEMENTS _over time_

Avastin -

Looks real good - same PROTONS and ELECTRONS - (as L)
and alot CHEAPER.

There are various anecdotal stories about it accumulating
in the EYE - but w/o trial data - just pissing in the
wind ....

Gonna sleep on this ...

Do you have a mayonnaise jar (Johnny Carson) that I
might borrow -g-

regards
John



To: Arthur Radley who wrote (198)9/29/2009 1:21:59 PM
From: John McCarthy  Read Replies (2) | Respond to of 421
 
Arthur -

If you get a chance .....

a) Assume I was doing a 36 month trial
b) Assume I was going to FDA with 24 months data

c) Assume my 12 month data was OK - even better than OK
d) Assume my 24 month data was less than OK

e) Assume my indication had current treatments primarily
focused on holding the line vs vision improvment ...

Am I screwed?

EDIT
----
Do I have "wiggle" room in terms of preparing the
NDA?

regards
John