ACUS timeline

wustler

Timeline from Acusphere PRs:

1. December 10, 2008
Feedback received at the Advisory Committee

2.January, 2009
Discussions continued with FDA

3. February, 2009
The Company submitted a narrower claim with a potentially improved risk-to-benefit ratio.
The Company was also invited by FDA to schedule a meeting to discuss alternatives.
The Company is in the process of scheduling the meeting.

4. March 11, 2009
Complete response from the U.S. Food & Drug Administration (FDA)

5. March 31, 2009
Completed a successful Pre-Approval Inspection (PAI) by FDA
Working with FDA to determine the most appropriate path forward for Imagify

6. May 19,2009
Discussions with FDA continue regarding the design of the clinical program.

7. May 31, 2009
Imagify decision date based on March, 11 2009 CRL reagarding broad use

penguin

irememberfaz

谢谢您的信息,可是这个是我从刚才有个帖子推荐的网页上看来的,怎么不太一样啊?昨天高点进了ACUS,今天深深水下,不是不信任XXTRADER,是心里有些嘀咕.

The previous estimated decision date for Acusphere in the BioMedReports.com FDA calendar for Imagify was 5/31/09. However, since the FDA issued a CRL on 3/11/09 for the original NDA with a broad claim of use label, the exact timeline for a new decision on the amended NDA with a narrower claim is still pending.

wower

Very nice, thanks!

wiggler

thanks

wustler

3# irememberfaz


This is the description from the same author on 04/09

"Amended NDA for Imagify (Perflubutane Polymer Microspheres) for Injectable Suspension as a cardiac imaging agent for the detection of coronary artery disease. Amended indication would be limited to subsets of patients undergoing pharmacologic stress techniques compared to original request for more widespread use with an expected PDUFA decision date of 5/31/09."

So the 5/31 is for the original claim. I am not sure if the amended request still shares the deadline and the request was submitted before the CRL was received.

On the other hand, per google discussion borad, this author now believes that the amended the request is off the table because of the wording used in the latest PR regarding the design of the clinical trial for the purpose of the original claim. Ironically, if that's the case 5/31 is the deadline for that claim.

So this guy gives at least 3 different estimate:

4/9: He mentioned amended claim for narrower use and still list 5/31 as the deadline for PDUFA decision--and a date to play with
5/19: Based on the exact same information, he claimed the decision date was pending because of the amended claim
5/20: He believes the amended claim is off the table without any substantial proof, however if true, 5/31 is still the deadline but possibly will be delayed into Q3

As I replied in another thread, giving the going concern of ACUS, it's hard for them to survive beyond Q3, and such a trial could be costly (this is the reason why a narrower claim was submitted in the first place), I guess there might be some compromise or partnership to either get the narrower claim proved or going forward to achieve the broad claim.

Lastly, in the author's 5/19 article he did mention that "The goal of the amended NDA and narrower claim for Imagify is to improve the risk/benefit ratio for the cardiac imaging agent by limiting its use to patients undergoing pharmacologic stress tests so that additional clinical studies are not required as outlined in the CRL from the FDA"

kdhsueh

I like to keep faith, I wish I could, let's see what happen next ....

wustler

I still think 5/31 is in play. The facts are always there. Nothing has changed about the claims except for the change in PR's wording which might hint for the direction this is heading to. These so-called analyst would change their tones to help manipulate the stock. I would agree with xxtrader, buy dip or hold till before 5/31 to ride the run up.

逆水之舟

thanks

xiaofengling

要看清后再买，我也是跟风买了ctic,bee,现在都在深水里。炒垃圾股比炒一般的股票赔的还多。要小心啊！

xiaofengling

我刚看了一位邻居的日志，讲HEB要快卖了，你们查查，他的id叫hot...，我忘了。
炒垃圾股暴涨暴跌，要小心。

wugang1976

really?

EDWC

thanks !