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ALXA halted?
INCY halted?
WATERTOWN, Mass., Nov 11, 2011 (BUSINESS WIRE) -- pSivida Corp. /quotes/zigman/111048/quotes/nls/psdv PSDV -53.69% (asx:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today reported that its licensee Alimera Sciences, Inc. (Alimera) received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for ILUVIEN(R) for the treatment of diabetic macular edema (DME) associated with diabetic retinopathy.
The FDA stated in the CRL that it was unable to approve the ILUVIEN NDA because the NDA did not provide sufficient data to support that ILUVIEN is safe and effective in the treatment of patients with DME. The FDA stated that the risks of adverse reactions shown for ILUVIEN in the FAME(R) Study were significant and were not offset by the benefits demonstrated by ILUVIEN in these clinical trials. The FDA stated that Alimera will need to conduct two additional clinical trials to demonstrate that the product is safe and effective for the proposed indication. Alimera reported that it will be requesting a meeting with the FDA to clarify next steps.
"We are obviously surprised and disappointed with the FDA's decision," said Paul Ashton, PhD, president and chief executive officer of pSivida.
Alimera reported that for Europe, Alimera expects to submit its formal response to the Preliminary Assessment Report to the Medicines and Healthcare products Regulatory Agency (MHRA) later this month. Alimera stated that based on this submission, the MHRA is expected to make a recommendation on the approvability of ILUVIEN for DME to Alimera and the Concerned Member States (Austria, France, Germany, Italy, Portugal and Spain) by the end of this year, with a decision regarding the approval of ILUVIEN for DME expected in the first half of 2012.
BZCN 200M
Volume increasing, ready to take off.
BZCN, someone just bought 115M shares. It's time for the yearly run this month...
Loaded up BZCN for the new year's run today
It's time to move up. Let's hit 0.02 today
http://pr-usa.net/index.php?option=com_content&task=view&id=916318&Itemid=30
Nice run the last couple of days
ALXA on the move. +6.50%
New plays in oktober or is this thing death?
BPAX(11/14), AIS(12/8) and ALXA(02/4/12) are on my list for the next months.
Added more ANX today. Hopefully it goes up now...
And what about PATH?
No news about the share-structure on 28 july?
Dilution?
Bought some more ANX two days ago. Hopefully we go higher for a few days...
Bought some more ANX yesterday. I'm glad I did.
ALXA moving up, I bought some more @1.75
When do we expect some news on ALXA? 01/07 or later?
I'm planning to buy some shares of NEOP. Good entrypoint or is it going further down?
ALXA slowly up every day...
Bought 3000 shares of ALXA yesterday @1.65. I hope it will run this month with at least 25%...
Can anyone tell me when there's an update?
OPTR sell off after the news?
A scam, yeah and I am Santa Claus.
Partnership with apple... Great
What news today?
Great news today. When merger is going through this will be a rocket.
December it's GRWW time. Weeeeeeeeeeeeeeeeeeeeeeeeee
If I was you, I didn't sell today. The run is about to start.
Next week will be great!
Go PCLI!
40-bagger again, hold your shares and you will be rewarded.
That break of the 9s will be this week.
Drilling results in a few weeks.
Speculation will get this much higher.
50milj, 1MM left on 8
BZCN today at .001 Weeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee