Thread: PSDV - pSivida Corp.

Guys viola .......this stock will be seeing some HGSI ness increase in the next couple of weeks.
The Drug:
Iluvien is an investigative, extended release intravitreal insert currently under development for the treatment of DME. Each Iluvien insert is designed to provide a sustained therapeutic effect of up to 36 months, for the low dose Iluvien, and up to 24 months, for the high dose of Iluvien. Iluvien is inserted into a patient's eye with a needle two thousandths of an inch in diameter, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.

There is currently no other medication in the market to treat macular edema as a result of diabetes.......if phase 3 results are positive expect a huge increase

Thanks for the info. Sounds promising.

Originally Posted by Spunk

Guys viola .......this stock will be seeing some HGSI ness increase in the next couple of weeks.
The Drug:
Iluvien is an investigative, extended release intravitreal insert currently under development for the treatment of DME. Each Iluvien insert is designed to provide a sustained therapeutic effect of up to 36 months, for the low dose Iluvien, and up to 24 months, for the high dose of Iluvien. Iluvien is inserted into a patient's eye with a needle two thousandths of an inch in diameter, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.

There is currently no other medication in the market to treat macular edema as a result of diabetes.......if phase 3 results are positive expect a huge increase

Important Notes: The 18 month data I list below is what gives me pause to buying this stock. Keep in mind that the 18 month data had only 37 people in it while the 24 month data has almost 1000 in it.


The data at 18 months showed that the low dose had decreased in efficacy when compared with the data at 12 months. The high dose showed an increase in efficacy when compared with the data at 12 months. The 12 month data showed 23.5% of the High patients experienced IOP increases of 30mm of mercury while the 18 month data showed 29% of the patients percent experienced IOP increases of 30mm of mercury, a 5.5% increase.

If 24 month data continues this path the lower dose efficacy would decrease even further and the higher dose would cause more patients to experienced IOP increases of 30mm. This does not bowed well for the drug or it's chances with the FDA. But again, having such a small data set at 18 months makes all of this a gamble and not comparable to HGSI whose data pointed towards a very likely and successful phase 3 results (which they were).

Originally Posted by marketwatch

Important Notes: The 18 month data I list below is what gives me pause to buying this stock. Keep in mind that the 18 month data had only 37 people in it while the 24 month data has almost 1000 in it.


The data at 18 months showed that the low dose had decreased in efficacy when compared with the data at 12 months. The high dose showed an increase in efficacy when compared with the data at 12 months. The 12 month data showed 23.5% of the High patients experienced IOP increases of 30mm of mercury while the 18 month data showed 29% of the patients percent experienced IOP increases of 30mm of mercury, a 5.5% increase.

If 24 month data continues this path the lower dose efficacy would decrease even further and the higher dose would cause more patients to experienced IOP increases of 30mm. This does not bowed well for the drug or it's chances with the FDA. But again, having such a small data set at 18 months makes all of this a gamble and not comparable to HGSI whose data pointed towards a very likely and successful phase 3 results (which they were).

very interesting observation

from the comparable drugs on the market i feel that they are right where they need to be although like you said the sample size is very small compared to the larger 24months analysis

investing only what i can afford to lose

Alot has happened since the last post:

* Alimera went public @ $11.00 a share

* Alimera filed with the FDA for Priority Review and they granted it

* Citi came out with a recommendation for Alimera (ALIM) with a target
price of $15.00

* Alimera and PSDV should be in front of the FDA for a YES/NO decision sometime in Dec 2010

* The drug Lucentis (approved for AMD) and used off-label for DME (with success) sells for
$2000 a MONTH which means that a 3 year supply DOES cost $72,000

* Per the Alimera roadtrip Alimera's mgt said that they estimated the cost of Iluvien
to be around $5,000.

* So for a 3 year timeframe its (a) pay $72,000 or (b) pay $5000 AND avoid all those
MONTHLY needles in the eye.

* The P3 trial (using the INTENT TO TREAT METHOD) was a success.

* The P3 trial using the Modified Arts method was a success in 3 out of 4 cases.
(The 4th case's problem was that some people who were supposed to receive
Iluvien did not show up to take it)

* Citi thinks ALIM will get 9% market share after 24 months. (Their NUTS)

* Iluvien will capture 25% market share after 24 months.

-- Cost
-- Convenience
-- Equivalent or better efficacy

And results kick in starting in the 3rd week.

* PSDV will get $25 million on FDA approval

* PSDV will get 20% of profits - forever.

* Alimera has already filed in Europe will soon file in Canada. I forget when
they file in Asia.

Originally Posted by JohnM3

PSDV - pSivida

(a) Indication: DME
(b) USA Market Size
per President: $1 Billion to $3 Billion
(c) Phase 3 results: Dec-09 release date
(d) Product:IIuvien

a combination of a nano-tech thingie containing
the FDA approved drug fluocinolone acetonide (FA)

August 2009 Presentation
Error Report

They just released similar presentation at R&R in 9/9/09
Wall Street Webcasting - pSivida Corp.

(e) PSDV existing FDA approved products thus far

Vitraset - partner B&L
Retisert - req operation - partner B&L

IOW - nano thingies already in humans and nobody has
turned into ET ... yet ....

(f) The IIuvien product is partnered with Alimera Sciences - a
private company

Alimera Mgt
Management Team | Alimera Sciences

(g) As I see it - upcoming investor milestones

* Release trial data Dec-09
* If OK - submit NDA Apl-10
* Request "Expedited Review"

This would reduce approval YES/NO timeframe to
Sept/Oct - 2010

WARNING:
THIS IS A CRAP SHOOT.
IF THE TRIAL FAILS PSDV (imo) is OUT OF BUSINESS
cash wise ....

If the Trial succeeds I hope they try a 2.0 million++
share offering .... ++ potential for cash from
those warrants - but I don't know the terms

FDA approval is a whole different matter but lasers
approved for DME *suck* and there are no other
approved therapies. Drug *stuff* is about 2 years
behind.

Notes:

Very low daily share volume
Bid/Asked spreads as much as 25 cents
18 million shares outstanding
13 million warrants ($7) outstanding

(h) In the wings -

- PSDV is too cash poor $8 million to carry out
full blown Phase 3 Pancreatic trials - but thats
where they are going

- Phase 2a - 17 people - avg life time 309 days vs
expected 178 days - safety trial - Pancreatic Cancer

pSivida's BrachySil in Pancreatic Cancer Study Results to be Presented at the ASCO Gastrointestinal Cancers Symposium - Drugs.com MedNews

- Phase 2b - 6 people - london - dosing ranging trial
on people expected to die within 6 months from - Pancreatic Cancer

One patient who started Jun-08 was on BBC Mar-09

Brachysil | A-2-Z About Cancer

Their enrollment has completed
pSivida Corp: Enrollment complete in BrachySil Dose Ranging Study | Reuters

- Pancreatic Cancer product called P32 Biosilicon - or
Brachysil

The statistics below were given by the
President of pSivida (PSDV) on 9/10/2009
at the R&R conference.
.
.
Notes from the presentation:
.
.
Back Eye Market Size
---------------------------
AMD Dry - 1,700,000AMD Wet -
300,000
---------------------------
AMD Total 2,000,000
====================
.
.
Glaucoma - 4,000,000
.
.
Diabetic Retinopathy
--------------------------------
DME ..................... 1,000,000
Diabetic Proliferate - 3,000,000
--------------------------------
Diabetic Retinopathy 4,000,000
==========================
.
.
---------------------------------------
Total Back Eye Market Size - 10,000,000
===============================
.
.
Lucentis is realizing revenues of $800,000,000
for its AMD Wet application.
.
.
If IIuvien clears the FDA the market opportunity
is between $1 billion to $3 billion per the
President of Psivida.
.
.
Source:
Wall Street Webcasting - pSivida Corp.
.
.

Here is a post by pharout912 on yahoo that provides a brief history of the company
and where they are today .....

------------------------------------------
For those new to this stock a little history PSDV was a AU based company that was poorly managed and while getting licenses for technology they had no clue about what to do with it. They did a number of very poor financings and these hung over the stock until 2007.

The one thing they did right was buy ( merge ) with Control Delivery Systems which gave them access to all of the current eyecare technologys. Over a period of several years CDS's management (Ashton et al)took over PSDV. They got rid of technology and / or licensed it out to stop the finaical bleed. During this time they came under great financial duress as an old financing allowed a group to actively short the stock... to make a long story short PSDV current management did 5 things right.

1)Focus on core technology and trials by selling off the non-core deals ( neutraceticals anyone?)
2) Cut Costs (staff associated with non-core)
3) Decrease cash burn by reworking license deal and insure they could get to 2011
4) Write-downs of IP (non-recurring) to get things in line as they got rid of some of the chaff. This will help in the future as they have bitten the bullet.
5) Make it a US based business

These things took time and money and slowly PSDV got on track only to be hammered during the market pull back of last year.

In my view this is a valuation deal. What are the royalties of the drug going to be worth? Remember, they have to do little to make money as there is no real performance required. So lets ask a simple question, what if their royalty income is 15M ( very very conservative IMO). For me I think that means about 225M in value on the very low end and this could easily go to the 350-400M range with strong sales.... now don't forget the one time payments of 25M on approval (I expect it early 3rd quarter of next year - for the people who say a year after NDA please look at other recent timeframes)and 15M when their partner raises capital or 2001 whichever is first so now you have 40M cash hord and a real going concerm which is ripe for the picking..

As far as PPS I think value is the whole deal... do your own analysis and then divide by 18M and you have it... and that assumes their is no value placed on 40M in cash. Also, it does not place a value on the technology... which put in the right hands could be huge.

Here is my time line

- Early October confirmation of completion of the trial
- Early December - Release of Data.... this will be big deal if it is anything close to the PK study, which I fully expect
- February 2010 - Filing of NDA w/ expidited approval
- July 2010 - FDA Approval

I know it seems like a long time but don't forget as this continues to move along this path I have included no other deals / announcements and once that initial data is released they will show up on everyones radar....maybe a deal or two? Don't forget big boys like doing deals with companies that have just reported great results.

Ohh just a note.. the insiders have sold nothing. They are in for the ride and to me that says it all.

Hope that helps.. happy hunting.

PS. Froma technical standpoint $4-5 is going to be a hard slog. Once this clears I expect that there will be much stronger upward momentum. This is not a day traders stock IMO because with the key blocks not selling the MM's will run it up and down and take money from those who can't afford to hold and gamble a little.

Yahoo! Message Boards - pSivida Corp. - RE: A Little History