acus

comet

There was never a decision date set for 5/31/09. The original date to receive the CRL was 2/28/09 and the amendment was sent prior to that date. When Acusphere sent their amendment for new indications they sent out a statement saying that it was "likely" that the FDA would push back the date for their CRL until 5/31/09. Somehow people ran with this date thinking that it had been set as a decision date, but it was never mentioned again but Acusphere or the FDA. After this statement was released, on March 11, Acusphere received their CRL. Acusphere then stated that "they" not the FDA, were trying to set up a meeting and nothing further was said about this meeting.

comet

http://seekingalpha.com/article/ ... e-aspenbio-alkermes

Here is the link. Any inputs ? It seems there is nothing for  ACUS on May 31st

wustler

The CRL on 03/11/09 has nothing to do with the amended claim. It's for the original broad claim. Based on the submission date of the amended claim, the estimate PDUFA target date for the amended claim is 05/31/09 as estimated in their 02/17/09 release.

wustler

2# comet


check this guys previous posts:
http://seekingalpha.com/article/ ... t-paid-9-more-to-go

http://seekingalpha.com/article/ ... w-product-decisions

He listed 05/31 as the PDUFA target date based on the same press release. Then on his 05/19/2009 he changed his tone saying the decision date for amended claim is still pending

farshine

moon2966

发动机

EDWC

Nothing will happen for  ACUS on May 31st?

comet

4# wustler
Yes. That guy changed his tone. But still, some investor emailed the ACUS and got reply from their investor relationship dept. It said that they are not expecting any action from FDA on May 31st. I believe that's the reason ACUS dropped from 49 cents to 31 cents.

I am not saying that ACUS won't go up in the future. But at least for short period of time. It will stay low and drop more.

yeah2000b

wuyanwuyan

Be careful about these garbage drug stocks. MM pump and dump them. ACUS dropped 50% in a day.