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A.P. Pharma Shares Gain Ground Ahead Of FDA Decision
http://www.rttnews.com/Content/BreakingNews.aspx?Id=1244890&SM=1
A.P. Pharma Shares Gain Ground Ahead Of FDA Decision
3/18/2010 10:03 AM ET
(RTTNews) - Shares of A.P. Pharma Inc. (APPA: News ) are currently trading over 10% at $1.72 ahead of the FDA decision on the company's lead product candidate APF530 for chemotherapy-induced nausea and vomiting. The FDA is scheduled to announce its decision today (March 18).
A majority of patients receiving chemotherapy experience nausea and vomiting. Since CINV (chemotherapy-induced nausea and vomiting) can lead to patients discontinuing chemotherapy, prevention and control of CINV is important in the treatment of cancer patients.
by RTT Staff Writer
For comments and feedback: contact editorial@rttnews.com
If the FDA has already decided and given the response to the company during marketing hours this morning, and if that same information is not news reported until the next business day, then I am expecting it to not be good news. I only say this as I have seen one other company I was following do the same process and it was not good news.
I really am not sure when the FDA will give out the information, so I was hoping it would be this morning. I have seen some reports actually given out several days early, but not sure how that would come about.
It could very well be that the FDA does not release anything until the end of trading day, assuming they have finished reviewing everything.
buy4fun, to be honest I really am not sure where it may go from here... but IF it is fully approved on all 4 types, then i would expect this to run over the next 2 to 3 days without taking any profit. i could see it running 3 or 4 days based on some other stock i have seen run. but you never can tell what will happen so it is hard to really guess in my opinion.
Buy/Sell Volume (3:1) 503,649:168,771
Please ignore this prior posting. I know why the difference now... I was looking at intraday, but in looking at daily it was the same.
Nice to see a rise of 10% instead of a fall of 10%.
I was hoping the news would have been out at 8 or 9 AM this morning. Maybe it is on it's way.
Now why could we not have stayed at this level the last two weeks instead of falling as we did. Not looking for an answer, just expressing a feeling here... I could have made alot more money. lol.
Have looked for news and see none out yet. Nothing on Fidelity or E*trade, or the web, or A.P. Pharma's website yet.
She's running... 1.75/1.78
Hopefully on a continuing rise thru the day.
Higher volume into the buying, which usually is a very very good sign. If it dips on very low volume, then that is good as well as not many want to sell on the dips. All very bullish if this is the case.
I am not sure if I have seen this before in NSDQ posting Ask bids in the $6 and $8 ranges before today, and if not they are showing up today for this stock.
PreOpen Bid/Ask: 1.72/1.80 1.80 already.
Already see a 1.80 trade for 2500 shares this morning.
I am so ready to hear the final results.
I feel like I have been watching a long awaited Award show and the final minutes are upon us, waiting to hear .... And the Winner is.....
I hope at least the FDA will report a final decision today, and it would be nice if it came out at 8 AM this morning. I think, maybe more hope, that the faster it comes out in the day the better the news will be.
I have my stock price alerts set so if it pops or drops during normal trading hours, then I should be able to hear the beeps during the trading following an anouncement.
Good luck to everyone, no matter what your position is. Though I am holding long I can not help hoping that we get positve news on all 4 types being approved and that we see a tremendous pop in price.
Something I think we all need to remember.
I hope it is ok for me to state this here as I feel a little concerned on some of the things I have been hearing here lately. This posting is just my feelings over the last several days, so I hope it is ok for me to say it here.
We all have an opinion that may be different from another person.
We all have a feeling on what is best to do, and when we maybe should do things on this stock.
So long as we all say in a friendly and constructive way what we feel about this stock and why we feel that way can be a good thing. Not all of us will agree, which is ok, but it could give us insight into something we did not think about before.
I, for one, before felt this stock should be heading over $2 and stay there. This could possibly be looked at "pumping" the stock to make other people wanting to buy in and help me by keeping the price up and making more money; or that maybe I am trying to get it higher so I do not lose any money if I had bought higher then where is it currently standing when I posted the message.
I could also be saying I feel you should be selling the stock as I feel that it will be dropping soon. Some may look at this as "bashing" the stock. That I am either shorting or wanting to get it lower to buy in at a lower price and then hope it rises again.
We all have a feeling/thought on were this stock should be at, where it may be heading in price, as well as possible FDA approval/denial. I think so long as we keep our postings on this board as informative and always showing respect to the board and readers on this site, then we can help each other.
I would suggest if you are going to post a comment that reflects something you are stating as a fact, then please post a link to where you are seeing this to share with the reader. If it is a thought or feeling you have, then just let the reader know this is how you are feeling it may happen and why.
I have been feeling lately in reading that some strong feeling comments are being tossed around, and not always in a constructive friendly way. This is why I felt I needed to post something today as I have been feeling we are not respecting each other's thoughts on what may be happening with this stock.
My personal thought is if you do not agree with someone, and have very strong feelings about it that could be considered confrontational, then either please keep the emotional feeling out of a public reply back on the board, or if you want to have that emotion included in the reply then you may wish to reply back with a private post so it is kept away from the other readers on this board. I think most of us want to be constructive and informative here and wish to help others out, no matter what your feeling is on this stock and where it may take us in price per share.
I hope this posting in itself is not out of line on this board. I do not mean any bad feelings here nor am I trying to be confrontational. This posting is mostly just trying to express my thoughts only on how I am feeling lately here. I think there have been a lot of good thoughts and information has been shared here and look forward to reading more of them.
Larry
Wow... never would have guessed this low.
A couple more days and hopefully we will have our answer, if not earlier.
Maybe I am looking at this differently than most, or just reading it differently than being asked.
I think the FDA will approve the drug on at least 3 of the 4 usages. These are the same 3 Aloxi are approved for.
I think the question is, will the 4th usage be approved, for Highly Delayed. This is the only one of the four that Aloxi is not approved for.
Aloxi is already the only company allowed to have it used for Moderately Delayed. 3 other companies are also approved on the Acute side (moderate and hightly).
PLEASE DELETE
Case 4, only the FDA can answer that when they make their determination. I am sure as with many people, it can depend on several things. How close is it to the target for approval; how are the people on the panel feeling personally; and do the people on the panel have any particular feeling for the company overall.
In otherwords, I wish I knew as I have no idea what so ever.
There are actually 4 possible usages of this drug, just as it was with Aloxi.
(1) Moderately emetogenic Acute CINV
(2) Moderately emetogenic Delayed CINV
(3) Highly emetogenic Acute CINV
(4) Highly emetogenic Delayed CINV
Aloxi is the only company so far approved for Moderately Emetogenic CINV. APF530 result shows Non-inferior to Aloxi, which should mean A.P. Pharma becomes the second company if approved by the FDA.
Aloxi had 3 of the 4 drug usages approved, APF530 was able to match and beat Aloxi on all 4, but that hard to reach one, the Highly Delayed is the 1 of the 4 that Aloxi was not approved for by the FDA.
Look here for the four possible usages.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=47825070
OK, it is really just one drug that handles both.
My feeling is that it will be approved by the FDA. That is assuming every i was dotted and t was crossed and blank filled in fully.
Vol: Buy 278,774 Sell 233,339
Looks like more buying into the Asking Price is occuring again. This is good to see. Hopefully the bottom has been hit and all we have to go is up again from here. If I knew this was going to happen I would have held off and bought into it now... laffs.... if I only had a wish
Congrats to those that are getting in at these prices.
Which 2 drugs are you referring about in the article you read back then?
Corrected numbers according to 10-K Report
Here are the numbers corrected for what was reported in a couple of earlier postings. I am taking my numbers from the 10-K report.
APF530's (10mg) Complete Response Percentage
Moderately emetogenic
(NI) • Acute CINV 76.9% for APF530 vs. 75% for Aloxi
(NI) • Delayed CINV 59.0% for APF530 vs. 57.7% for Aloxi
Highly emetogenic
(NI) • Acute CINV 81.3% for APF530 vs. 80.7% for Aloxi
(NS) • Delayed CINV 68.3% for APF530 vs. 66.4% for Aloxi
NI: Non-inferior
NS: No significant difference
All were considered Non-inferior, except for the Highly Emetogenic Delayed finding. All though it is a higher percentage then Aloxi, they rate it in their SEC filing as being "No significant difference". I have no idea how they determine which bucket they fall into, but either way I like the higher percentage.
Since Aloxi has not been approved for Highly Emetogenic Delayed CINV, does not necessarily mean APF530 will not be. The probability is surely higher that it will not be due to the "No significant difference" rating, but how far off it may be is something I can not tell so for me it is hard to say how the FDA may rule on this. If the FDA gives them the nod and approves it for all 4, then they will be the first to be granted this postion.
Even if only 3 of the 4 get approved by the FDA, with the drug able to be given via a shot to the patient opens up all new doors for this being used, where Aloxi can only be administer via an IV. Which in my mind makes this even more vital then Aloxi's drug.
buy4fun, I think it may be for several reasons.
My thoughts are the some are getting more nervous and thinking that maybe this drug may not get approved at all by the FDA, which I am guessing would be very little if any at all.
Another is that some are feeling that the FDA may only approve part and not whole of this drug in how it could be marketed.
I also think some are accumulating, but I am not sure how much in looking at the charts.
When I looked more into the 10-K filing with the SEC for year end, I did see some numbers that did not agree with what was posted here in an earlier post. Not a big difference on those few I saw, but I am going to look them over and repost the numbers the 10-K is reporting.
The message on this board relates to the last paragraph in (PART TWO - PHASE III STUDY AND APF530'S ADVANTAGES)
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=47296166
In the end I think some just are not sure what to do and selling their shares, while others are accumulating and holding.
I did see that 10-K report and posted it earlier.
This is the message I posted the link to:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=47812418
and reference the better loss in another link in response to another person here.
I don't think any new news is out, just some concern on how hard this is being pushed down and probably want to save some of their dollars put in.
14% down I would say from say an average price of $1.80.
28% off it's all time high of 2.16.
I have one of my two different brokerage accounts loaded to the max on this stock and riding it out to see what happens this end of week. I think the odds are in favor of a successful response from the FDA. Either I will turn out to be nicely rewarded or a darn fool.... laffs... they say you never should put all your eggs in one basket. This one I have for at least the one account.
I am just as nervous as you all are, but also feel very good about it.
Vol: Buy 139,788 Sell 196,380
and another 26,101 shares that they can not tell which side they should sit on. My guess more because of time of execution and possibly buy/sell prices being the same.
These numbers are according to this site in looking at the Trades section.
I was seeing the rise up first thing... until ISEG jumped in and has been placing some large orders and pushing it down. If they wanted top dollar for selling, they should have let it rise up as it was pushing that way. Can only guess why they are pushing down.
Due to them we are high on the Selling Volume. That is selling into the Bid Price.
MrRawlins, For me this morning I was focusing on the loss per share
Basic and diluted loss per share for shares ended December 31st:
Here are the numbers for the years 2009, 2008 and 2007 in order.
Loss from continuing operations
$ (0.31 ) $ (0.74 ) $ (1.02 )
Net loss
$ (0.31 ) $ (0.75 ) $ (1.04 )
Buying Volume Higher versus Selling Volume.
More trades are executing (buying) at the Asking Price this morning then are those traders wishing to sell at lower (Bid) prices.
Buy Volume: 41,288
Sell Volume: 33,155
Hopefully the good news (as I took it) from the Sec Filing for end of 2009 is helping today also.
Form 10-K AP PHARMA INC /DE/ For: Dec 31
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6830662
APPA - Looks like good news to me in the SEC filing. Thanks for posting.
Not new News, but nice to still see it being good out there the weekend before FDA notification.
Same story on both links.
http://www.emailwire.com/release/36013-AP-Pharma-Inc-Public-NASDAQAPPA-PDUFA-Date-of-March-18th-Rapidly-Approaches-for-APF530.html
http://www.thefirstreporter.com/press-releases/a-p-pharma-inc-public-nasdaqappa-pdufa-date-of-march-18th-rapidly-approaches-for-apf530/#axzz0i5HPVVPb
A.P. Pharma, Inc., (Public, NASDAQ:APPA) PDUFA Date of March 18th Rapidly Approaches for APF530
Many factors influence the FDA’s decision when considering a drug candidate for approval. In this case, there are some factors that weigh heavily in favor of A.P. Pharma, Inc., (Public, NASDAQ:APPA).
(EMAILWIRE.COM, March 13, 2010 )NY,NY TapeBeat.Com, the news and research portal for the serious investor is proud to present information regarding A.P. Pharma, Inc., (Public, NASDAQ:APPA) a specialty pharmaceutical company based in Redwood City, California. Its current pipeline utilizes a group of polymeric compounds dubbed Biochronomer as its drug delivery mechanism with a number of advantages over current delivery means. Probably the most important advantage of the Biochronomer system is that the actives (drugs) can be incorporated into a drug matrix by simple physical mixing means that allow injectable gels, microspheres, coatings and strands to be created depending on the necessary application. Each of these different forms is capable of controlling site and speed of the active ingredient delivery without the use of active and sometimes questionable liquids such as solvents in the finished drug product.
Currently there is only one drug approved for both acute and delayed onset CINV via serotonin 5-HT3 antagonists, Palonosetron. Serotonin 5-HT3 antagonists work by blocking the effects of a chemical called serotonin, which is produced in the brain and stomach. They prevent and relieve nausea and vomiting caused by chemotherapy. APF530 works by utilizing its delivery system and the 5-HT3 receptor antagonist, Granisetron, as its active ingredient. Granisetron was approved by the FDA for the treatment of acute onset CINV in 1994. The patent on it expired in 2007, so it is freely available for use in APF530.
An advantage of utilizing a previously-approved active ingredient is that the NDA can be submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act in which the application can rely upon the FDA’s previous safety and efficacy profile for APF530’s active ingredient. For further information on how this may favor approval of APF530 please visit TapeBeat.Com for the full story.
Stephen Ramsey
Philip Runfeldt
Staff Writers
Mr. Ramsey is long APPA
By viewing this information you agree to the disclaimer found on TapeBeat.Com. The opinions expressed are that of the individual contributor(s). Neither the company releasing this information, nor the contributor(s) are associated with the company(s) mentioned or acting on their behalf. Neither TapeBeat.Com nor contributor(s) are certified financial advisor(s) or professional analysts. This is not a solicitation to trade in any security or a recommendation. Please do your own due diligence as, trading could result in loss of your principal.
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Well today was pretty flat. Not much change at all.
bluemonstr, for what is it worth, I was about 40 when I got involved with stocks.
Hi bluemonstr, regarding Buy/Sell Volumes....
I am not one that knows it all and I am still learning many things as I continue to trade stock and in being on this website.
When I refer to Buy and Sell Volumes, you have to think of it this way.
When a trade occurs from an Ask Price, then that is considered a Buy Volume. Someone is willing to pay a seller at their Asking Price.
When a trade occurs from an Bid Price, then that is considered a Sell Volume. Some Seller is willing to sell their stock at a Bidders Bid Price.
It can be kind of hard of at first, as I had to think about it when I came across that way to look at stock and not just in total volume by itself. Basically you are looking at how the trades seem to be occuring.
One bad thing is that shorters and MM can help push a stock down and not allowing it to flow as the real trading may wish to flow.
Big price changes can occur up or down more when stocks have low daily trading volumes, such as APPA has. There are many others that trade in the millions and tens of millions each day that does not have as much movement.
When there is such a large imbalance between the volumes, you could see at the end of day, a very large volume purchase or sell off to help. I think this happened for 3 out of the last 4 days.
Cincinnati Exchange jumped in again at 1.67. Looks like another push down due to them but still holding around 1.64/1.65.
If we can keep Cincinnati and ISEG from holding this down IMO, then I would expect us to be able to get to 1.70 easily.
Buy/Sell Volume Update for last 1/2 hour.
Buy volume up 14,000
Sell volume up 6,000
Momentum Line also looks to have bottomed, and if so then I would expect a rise from here. Just need to wait a little longer to better tell.
Buying/Selling Volume over last hour.
For what it my mean, the Buying volume for the lst hour has been about 26,200 shares, versus Selling volume of 4,800. Makes me still feel the price is being held down and not allowed to rise.
I noticed the Cincinnati Exchange was one of the exchanges that was seeming to keep this being held down. I think ISEG was one of them as well.
Yes as my prior posting from last shows you why.