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Agent & Drews Bio Plays - Page 9

post #161 of 586
Thread Starter 
In at .55 - Whoops.
post #162 of 586
Quote:
Originally Posted by gambler2076 View Post
nice call...

g
Thanks G. How have you been doing?
post #163 of 586
XOMA still going. Not real happy about missing that one.
post #164 of 586
Thread Starter 
ANDS is a beast! HOD 1.25
post #165 of 586
Quote:
Originally Posted by Drewett27 View Post
XOMA still going. Not real happy about missing that one.
Ya, saw that sucker dip to 3.60 yesterday then decided to go with another play. I have no way of knowing how to evaluate these things in terms of where the price is going.
post #166 of 586
Quote:
Originally Posted by Drewett27 View Post
Thanks G. How have you been doing?
not bad, just amazed at the ridiculous bio moves so far... they seem to have come out of nowhere. Was trying to add 100K shares of PARD when it just ran away from me...

g
post #167 of 586
It's been a good week for them for sure. Hope it continues. I almost let PARD get away this morning as well.
post #168 of 586
Quote:
Originally Posted by Drewett27 View Post
XOMA still going. Not real happy about missing that one.
insert plank here_______________
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ME!!!!
post #169 of 586
Quote:
Originally Posted by 32flvrs View Post
insert plank here_______________
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ME!!!!
How much more momentum does this have?? Was waiting for Jan results.
post #170 of 586
Too risky for me to touch it at these levels.
post #171 of 586
RPRX broke out today as well.
post #172 of 586
Quote:
Originally Posted by Drewett27 View Post
Too risky for me to touch it at these levels.
ditto...waiting for the swan dive.
post #173 of 586
Quote:
Originally Posted by Drewett27 View Post
RPRX broke out today as well.
WOW
post #174 of 586
Unreal...XOMA still going
post #175 of 586
insane day today: RPRX,RPC,XOMA,ACAD it seems like the whole sector is running this week.
post #176 of 586
Thread Starter 
You guys still in PSDV?

WATERTOWN, Mass.--(BUSINESS WIRE)--pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIENĀ® for the treatment of Diabetic Macular Edema (DME), today announced that Alimera Sciences, Inc, pSivida's collaborative partner, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ILUVIEN. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

The NDA seeks approval to market ILUVIEN (fluocinolone acetonide intravitreal insert), an investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of DME. The ILUVIEN NDA was submitted to the FDA on June 29, 2010 with safety and efficacy data through month 24 of the FAME Study. The FDA granted the NDA Priority Review status on August 30, 2010.

In the CRL, the FDA asked for analyses of safety and efficacy data through month 36 of the FAME Study, including exploratory analyses in addition to those previously submitted in the NDA, to further assess the relative benefits and risks of ILUVIEN. Alimera has completed month 36 of the FAME Study and has reported that it is preparing the analyses that the FDA has requested. Alimera further reported that it has requested a meeting with the FDA to clarify the path to regulatory approval. The FDA did not ask for any new clinical studies in the CRL.

In the CRL, the FDA is also seeking additional information regarding controls and specifications concerning the manufacturing, packaging and sterilization of ILUVIEN, which Alimera reports it is in the process of compiling. Additionally, FDA indicated in the CRL that it had observed deficiencies in current good manufacturing practices (cGMP) during facility inspections of two of Alimera's third-party manufacturers, which were completed in August and September of 2010, and that all facilities and controls will need to comply with cGMP. Alimera reports that its third-party manufacturers are in the process of resolving these deficiencies.
post #177 of 586
Hope everyone has a Merry Christmas!
post #178 of 586
Thread Starter 
RPRX booming today! Woulda like to get in on that news.
post #179 of 586
What's the thinking on ALXA? They are due to have a FDA meeting this week and hopefully will see more run up.
post #180 of 586
Quote:
Originally Posted by Richie Rich View Post
What's the thinking on ALXA? They are due to have a FDA meeting this week and hopefully will see more run up.
I haven't done any homework on this one but I do have it on watch to see if it can break out of that flag formation to the upside on the daily chart.
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