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PVA, PSIVIDA CORP
diana
post Posted: Jun 29 2012, 10:16 AM
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Great announcement today and a very worthwhile exercise to follow the link to the Article/Report.
R/Di



--------------------
"Adversity does not build character; adversity reveals character."
Sandy Dahl
 
Capper39
post Posted: Dec 25 2010, 12:55 AM
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Well that was a bit of a let down.. But don't lose sight of the ultimate plan here & let's get a couple of things straight.

Alimera were on a hiding to nothing.

The 36 month trial data was delivered to Alimera mid-late November, 2010

By this time, the FDA was 5 months into its priority review of the Iluvien submission.

The had 2 options.

They could have supplied the 36 month data to the FDA, which certainly would have added extra time to the assessment, or wait for it to be requested.

If you are Alimera, why would supply it and hold up the process if you thought you'd get the tick of approval late December, 2010. In theory they could have started making sales 1st January, 2011..

At the same time, the FDA simply could not give approval based on 24 month data, when it knew full well that Alimera had the later 36 month data in their keeping.

If the approval was given and the 36 month data was later found to be ordinary, the FDA would look silly to say the least. Quite simply, the FDA had to request it.

In retrospect, Alimera should have volunteered the 36 month data, and copped the extra time on the chin.

Either way, the market would have viewed it as a negative and the SP would have been smashed. Only now, the market may take the view that the 36 month data was not volunteered because Alimera found it to be average.

For fear of sounding like the eternal optimist, i believe it is a good short/medium-term buying opportunity. I am a large holder, and fully intend to step-in if the price is right.

I understand Alimera & Psivida are confident with the 36 month data on hand and will provide all requested information in a very timely manner.

Would have loved FDA stamp of approval this year, but 2nd qtr 2011 looks more likely.

Good luck,

WC39


Said 'Thanks' for this post: maurie  
 
diana
post Posted: Dec 24 2010, 02:53 PM
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In Reply To: anselll's post @ Dec 24 2010, 12:16 PM

Ah well ... just another request for more info. They always do that ... gotta justify their salaries somehow.
R/Di



--------------------
"Adversity does not build character; adversity reveals character."
Sandy Dahl
 
anselll
post Posted: Dec 24 2010, 12:16 PM
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In Reply To: diana's post @ Dec 22 2010, 10:39 AM

Oops*#@!*!

CRL from FDA - bUGGER!

 
diana
post Posted: Dec 22 2010, 10:39 AM
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In Reply To: anselll's post @ Dec 22 2010, 10:20 AM

That would be nice ansell ...... as long as the price stayed the same. biggrin.gif

Maybe the New Drug Application has been approved. Was due about now if it was going to happen.

R/Di



--------------------
"Adversity does not build character; adversity reveals character."
Sandy Dahl
 
anselll
post Posted: Dec 22 2010, 10:20 AM
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In Reply To: diana's post @ Oct 18 2010, 10:50 AM

Red, Amber and finally Green - round the home turn!.

For the longer term holders, they need to re-consolidate the shares back up by 40 x it was previously reduced down to! wub.gif grrr.gif

 


diana
post Posted: Oct 18 2010, 10:50 AM
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In Reply To: diana's post @ Sep 24 2010, 10:17 AM

An excellent financial performance for PVA. It's high time the SP made some significant progress. EPS 46cps! Yippeee!!! biggrin.gif
R/Di



--------------------
"Adversity does not build character; adversity reveals character."
Sandy Dahl
 
diana
post Posted: Sep 24 2010, 10:17 AM
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<H4 class=rulebelow>US HOT STOCKS: Saks, Lions Gate, Alimera, Dean Foods</H4>01/09/2010 3:18AMU.S. stocks traded higher Tuesday as the Dow Jones Industrial Average climbed 36 points to 10045, the S&P 500 rose 3 points to 1052 and the Nasdaq Composite ticked up 1.8 points to 2122. Among the companies whose shares are actively trading in the session are Saks Inc. (SKS), Lions Gate Entertainment Corp. (LGF) and Alimera Sciences Inc. (ALIM).

A consortium of U.S. and U.K. private-equity firms has been pursuing an acquisition of luxury goods retailer Saks ($8.06, +$1.46, +22.05%), the Daily Mail reported, citing rumors. The British newspaper reported a cash bid of $11 a share, or $1.7 billion total, could be made. The stock last traded at that level two years ago and hit a six-month low Monday.

Activist investor Carl Icahn raised the price of his hostile tender bid for Lions Gate ($7.31, +$0.82, +12.63%) by 15% Tuesday as he continued to seek majority control of the film and television producer. The latest offer is for $7.50 a share. Icahn earlier this month extended the offer until Oct. 22, saying the move would give a Canadian court more time to consider his lawsuit against Lions Gate.

Biopharmaceutical company Alimera Sciences ($8.75, +$0.65, +8.02%) said its new drug application for its diabetic macular edema treatment Iluvien has been granted priority review status by the U.S. Food and Drug Administration. That status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time to six months from 10 months. PSivida Corp. (PSDV, $3.59, +$0.33, +10.12%), which licensed the drug to Alimera, also gained.

Dean Foods Co. (DF, $10.41, +$0.61, +6.22%) traded at the top of the S&P 500 Tuesday on higher-than-normal volumes. Word was there was an old rumor making the rounds again, that French dairy giant Danone SA (DANOY, $10.74, -$0.04, -0.37%) is making a go at the U.S.'s largest dairy producer. Analysts called it an unlikely pairing, though. Dean Foods declined to comment on speculation but said it "continues to evaluate all of our businesses on an ongoing basis... We explore options and make choices based on what's in the best interests of our company, our customers and our people."

Winn-Dixie Stores Inc.'s (WINN, $6.95, -$1.07, -13.34%) fiscal fourth-quarter profit climbed 49% as the regional supermarket chain's results benefited from an extra week in the latest quarter, although same-store sales slid as the company moved to protect margins. Earnings topped expectations, but revenue fell short.

Isle of Capri Casinos Inc. (ISLE, $6.87, -$2.00, -22.55%) swung to a surprise fiscal first-quarter loss as the regional casino operator saw revenue decline across all of its regions except Mississippi, which got a boost from its recent Rainbow casino acquisition.

Energy Conversion Devices Inc.'s (ENER, $4.61, +$0.63, +15.82%) fiscal fourth-quarter loss widened on sharply higher costs, outpacing strong revenue growth for its solar products and services. The results topped analysts' expectations, but the solar-panel maker forecast revenue for the new year and the first quarter below analysts' average estimates.

Mediacom Communications Corp. (MCCC, $6.01, -$0.84, -12.26%) founder and Chief Executive Rocco B. Commisso withdrew his offer to buy the company Tuesday, following what he called he board's rejection of a "meaningful increase" to his initial offer price. Commisso in May offered $6 a share for the company, valuing the company at about $427 million. Commisso said that he decided to drop the effort after the board rejected the increased offer, which wasn't disclosed, and that it was contingent on being approved by holders of the majority of the shares Commisso doesn't own. His stake is about 40%.

Other Stocks In Focus ARM Holdings PLC (ARMH, $16.74, +$0.98, +6.22%) gained with some traders pointing to recent M&A news involving its rivals. However, one trader thinks the increased competition could be a potential negative for ARM, albeit in the long term. Another trader noted the relative strength of the sector of late, while a third says the launch of its next version of the Cortex A series processor that can run virtualization software is on the horizon.

Deutsche Bank cut ASML Holding NV (ASML, $25.04, -$0.41, -1.61%) to hold from buy and lowered its price target. Uncertainties including the peaking of mid-term share price drivers such as bookings and consensus upgrades, slowing demand for computers and chips, and new capacity addition plans being scrapped or postponed, prompted the downgrade. Deutsche did note the longer-term demand and capex outlook remains solid.

ATMI Inc. (ATMI, $12.80, +$0.34, +2.73%) said its board has authorized a share-repurchase program for up to $50 million. The company, which makes semiconductor materials and equipment, has a market capitalization of about $398 million.

An experimental blood-thinning drug from Bristol-Myers Squibb Co. (BMY, $26.09, +$0.24, +0.93%) and Pfizer Inc. (PFE, $16.05, +$0.19, +1.20%) cut the rate of strokes among people with abnormal heartbeats by more than 50% versus aspirin, and didn't significantly increase major bleeding, according to a study. The positive data may help strengthen the case for regulatory approval of apixaban, a drug that some analysts think could generate peak annual sales of more than $3 billion. Previous studies suggested apixaban was effective at preventing blood clots in patients undergoing orthopedic surgery.

Piper Jaffray raised its stock-investment rating on Codexis Inc. (CDXS, $8.11, +$0.21, +2.66%), a company that focuses on the cost-effective conversion of renewable resources into transportation fuels and pharmaceuticals, to overweight from neutral, citing potential commercialization catalysts.

Robert W. Baird raised its stock-investment rating on financial-services company Comerica Inc. (CMA, $34.75, +$1.31, +3.90%) to outperform from neutral, saying the recent sell-off in the stock creates an attractive risk/reward tradeoff.

(MORE TO FOLLOW) Dow Jones Newswires

August 31, 2010 13:18 ET (17:18 GMT)


At least something is happening somewhere. smile.gif
R/Di



--------------------
"Adversity does not build character; adversity reveals character."
Sandy Dahl
 
Capper39
post Posted: Sep 1 2010, 05:52 PM
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If and when (late December 2010-early January 2011) the NDA is approved by the FDA, PVA's licensing partner, Alimera Sciences (NASDAQ: ALIM) must pay pSivida US$25m + 20% of the profits from global sales.


Good Luck,

WC39

 
diana
post Posted: Sep 1 2010, 10:05 AM
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In Reply To: mongoose's post @ Sep 1 2010, 07:48 AM

I think you might be right mongoose. biggrin.gif
Great news ... not unexpected ... but excellent nonetheless.
R/Di



--------------------
"Adversity does not build character; adversity reveals character."
Sandy Dahl
 
 


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