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APPA looking good for bounce
APPA plunging on FDA news
FDA Sets Aside Approval Of AP Pharma's Lead Drug For Now >APPA
Last update: 3/19/2010 7:35:43 AM
DOW JONES NEWSWIRES
AP Pharma Inc. (APPA) said U.S. regulators need more answers about the company's lead drug candidate, a treatment for chemotheraphy-induced nausea, before they can approve the company's new-drug application.
The Food and Drug Administration said it has some worries about the dosing system, manufacturing of and data about APF530, which would be the second drug on the market for chemotherapy-induced nausea and vomiting if approved. Shares plunged 63% to 76 cents on the news. The stock had doubled the past three months.
AP Pharma has been waiting on FDA approval before pursuing partnership talks for marketing the drug in earnest. Although the company could market the drug on its own, Chief Executive Ronald Prentki had indicated the company was willing to wait for approval in order to get the best deal.
Friday, the company said the FDA was worried about the drug's two-syringe dosing system, including potential problems transferring material from one syringe to the other or the possible risk of improper administration.
The agency also identified deficiencies at some of AP Pharma's contract manufacturing facilities, which must be resolved. It wants the company to switch to a terminal sterilization process before approving the drug.
Although it didn't request any more clinical studies, the FDA wanted AP Pharma to review its existing late-stage trial data and reanalyze it. It requested the company do studies related to bioavailability, metabolism and heart arrhythmia, which AP Pharma said it expect won't take long. The agency also declined the company's request to waive a thorough QT study, which AP Pharma also said shouldn't take long.
The company had to cut more than a third of its work force last year and shelve several early-stage development programs to conserve cash, vesting a lot of its future success in APF530. The treatment would compete with Eisai Co.'s (4523.TO, ESALY) Aloxi.
-By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; joan.solsman@dowjones.com
(END) Dow Jones Newswires
March 19, 2010 07:35 ET (11:35 GMT)
New board on Pre-market and After hours movers....feel free to join the conversation http://investorshub.advfn.com/boards/board.aspx?board_id=17375
The pre market and after hour market, should basically eliminate the .0001 stocks too, feel free to post news, charts and invite others, thanks
Hello, Tanaka, this is a board for pre market and after hours moves, feel free to post strictly PRE-MARKET and or AFTER HOURS movers, with charts, news....
Test
Hello all, just created a new board, feel free to visit !
http://investorshub.advfn.com/boards/board.aspx?board_id=17375
knulp, get a clue, my friend, these pinkies never trade AH
HMNA taking a pounding, after some shmuck here started pumping it
FNLYQ ask getting hit, float must be gone
FNLYQ, float looking dried up here, ask getting hit
FNLYQ bid UTing
I wish I had a dime for everytime someone said something was a surefire 10 bagger
FNLYQ, needs a little more volume, should surge
I guess that means he's frontloaded to the gills and is going to dump into your buying...?
Well, ARCA is on the bid at .06, there was a small sell off near the close, then some buying kicked in, looking for this to still test and break the .11 mark by the open
TNXI ask getting slapped here !!!!!!!!!
TNXI, .11 ask is up now, once that breaks, it's GONE !!!
TNXI 42k @ ask, UT'd
TNXI needs .11 break, should clear .13 into blue sky after that
TNXI, last trade over 15 minutes ago....halted...?
TNXI needs to bust .11
I think you forgot reason #11. Because they are paying you X amount to pump it....?
ARCA filled PSGI order at .068, looks primed for .10+ today
ARCA has a buyer of 100k shares of PSGI @ .068 !
PSGI, UP 38% PM
MM ARCA on PSGI bid now .068 !!!!!
COIN, strong into close, AH runner...?
SHAR REVERSE SPLIT ?
FOYJ .063 x .0649, ask getting slapped
FOYJ, looking for .10 close
FOYJ warming up into close
Christ, I can't even locate this company on yahoo
FNLYQ, bid UT
MDXX sure looks like a pincher
This sounds like a fancy reverse Split...
Stock momo, always good to see the bashers show up....means we're ready to go
Mini shake on EGLSQ here, should run in power hour
EGLSQ breaks .03 here, easy run to .04s