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What are they doing with such small volume....walking it down to 1 cent?
They are just holding it down.
At any moment we could have a run to $1, you never know...
Lots of interest. People are waiting for the run to start, or the approval, whichever comes first.
3 year anniversary today of CRL
March 18 2010
The problem here is you have $200 worth of stock driving this down as everyone is holding.
this is unreal
Looks like everyone holding
Lets get moving this morning
easy $2 in first days of approval no question
It would be great to walk up one morning this week, go on their site and see a big fat "FDA APPROVES APF530" dreaming...wait is almost over...
http://seekingalpha.com/article/1133891-a-p-pharma-pdufa-date-on-apf530-looms-and-i-am-a-buyer
$4.40 with only an estimate of 200 million in sales
add some more sales and license of our technology, sky is the limit.
Haha yea I wish!
What a find here to show AP Pharma's success....no one here on he board as ever discussed this...
Retin-A Micro - Everyone has heard of it
http://www.highbeam.com/doc/1G1-141099975.html
Sold their rights to the drug royalties for 30 million to finance APF530 development. This is not their first go around.
Still holds all the patents to the Microsponge technology, even a lawsuit for patent infringement in late 2012 appears in Google search.
Interesting find and disproves all claims of fraud on YMB.
http://www.centerwatch.com/drug-information/fda-approvals/drug-details.aspx?DrugID=228
The best part is that we used our own funds to develop the drug and will be marketing on our own.
No Royalties=huge net profits
From my perspective:
1 of 83 do not get approved due to manufacturing
82 of 83 would get approved if it was a manufacturing issue.
82/83 (x) x/100
83x=8200
8200/83= 98.8% approval rate based on the fact that APF530 is safe, its a 505 submission(active ingredient is approved), the drug is effective with no major adverse side effects, and manufacturing/delivery was the main issue of CRL.
Why more drugs than ever are approved through 505 submissions
http://www.camargopharma.com/Userfiles/Docs/Cmrgo_WPCostEfficiencies_VF.PDF
Increasing or increased in quantity, degree, or force by successive additions.
50% get approved. But statistically it is 75% compared to first round.
But take into account only 1 drug never received approval because of manufacturing issues which is 1%.
APF530 main issues were manufacturing. Which have been corrected. The drug is safe and effective and the FDA has acknowledged that. They were only concerned about the manufacturing/QT/Delivery(syringe) this time around.
I am no genius, but statically speaking, you take into account 75% of all drugs are approved on the 2nd round..meaning only 25% do not get approved of all submission. Take the 1% that does not get approved due to manufacturing issues...and I am sure and Accuracy would be able to do the equation, and our chance of approval would be over 95%.
I will see if my brother(the accuracy) can do this for me later today.
Here is some good data on 2nd Submission. Near 75% get approved on the 2nd trip, up from 50% in round 1. Interesting note that from 83 drugs receiving CRL's only 1 never got approved because of a manufacturing issue and eventually was suspended by the drug maker. 3rd attempt goes up to 83% approval rate.
http://www.biotech-now.org/business-and-investments/2012/03/dealing-with-rejection-the-regulatory-kind#
Read this.
http://seekingalpha.com/article/1133891-a-p-pharma-pdufa-date-on-apf530-looms-and-i-am-a-buyer
There is no risk in approval.
Good thing we have this one which puts our target at $4.40 on 200 million in sales, only goes up from there.
http://seekingalpha.com/article/1133891-a-p-pharma-pdufa-date-on-apf530-looms-and-i-am-a-buyer
Still can't believe what happened with NAVB. I think its all because of this article with a mix of shorting.
http://seekingalpha.com/article/1072051-heads-you-lose-40-tails-you-lose-70-on-gamble-with-navidea-shares
Seems like they have a lot of pull on the market, from watching other runs go off their articles.
I am standing by with funds sitting in my account to go all in. I was hoping to catch NAVB, ZGNX or TTNP before APPA gets approved to get my cash up 20-50% to go all in with APPA on day 1. But will be happy with an early approval.
Currently have 65k shares.
It should get crazy in a week. New people posting, asking when it will be approved, what the drug is, etc.
On approval, Ha, this board will be lighting up.
I really do hope we get early approval.
On the other hand, have you ever seen or heard of a CRL early? or if by chance (less than 10%) they get one, will they just wait until the date to announce it?
From your experience , what does tomm. bring?
LOL Its 11!
I wrote the wrong number its
3+1+3+1+3=11
Looks like we both can't add, haha (=13)
3/18/13 Approval??lol
If math works out like NAVB
4/30/13 PDUFA date 4+3+1+3=11
3/13/13 Approval date 3+1+2+1+2=11
We are at
3/27/13 PDUFA date 3+2+7+1+3=16
3/18/13 Approval date 3+1+8+1+3=16
HAHA...someone off of YMG called it early this morning a few hours before approval.
got 4k just in case it pops
3 drug new approvals today on FDA database. good sign!!
Drying up right now.
Maybe this afternoon.
Huge Buy 250k @.64
Site must be getting alot of traffic. server is busy.
$10-20 target
You are so wrong.
We will have a 900 million dollar market
1 of 2 drugs, AP's drug treats a broader range of patients and will be superior.
Estimate 500 Million/year plus in Revenue
So in one year we get to $10-20 pps.
In addition everyone will want to license our drug delivery technology which will be proven effective on approval. That will being in another 100-200 million a year or more.
Add another 5 drugs into the pipeline.
In 3 years we will be bringing in revenue of 1 Billion.
So you change your username Barry, and now decide to pump?
what gives?
43k now, looking at adding 27k more....
I would like to hear your concerns as would the board. If you have information that is important which would be consistent with a possibility of not receiving an approval there are millions of dollars on the line from this board. Please do tell.
That doesn't matter. This about approval or not. This stock is worth $4-10 within 6 months to a year if approved if not sooner.
I will be standing by the week of the 27th. I am in 30k shares right now....but will liquidate all my assets on the 26th and if approved I just hope to get in before it reaches a 50% gain , but will go in up to $1.50/share if it is instant. I will hope to have at least 100-150k shares within the first hour of trade following approval.
If it gets approved...it will move up for sure! What are you smoking
7 Million shares 1 trade
I read their PR before resubmission where the company states all the deficiencies and actions taken but they mention not doing the study because the "company" concluded that it was not needed based on FDA discussions.
Anyway...I remember seeing Jazz back in June 2009, up 100% a I decided not to invest as I thought I was too late. It went up another 100% and so on eventually going up to 10, 20 and now in the 50's. This was all based on Phase 3 data of their JZP-6 drug which never got approved. But they had already had Xyrem(same drug JZP-6) approved since 2002 for a different purpose which is now bringing in 3-5x more earnings than the 100 million it was producing back in 2009. But the Committees recommendation propelled this stock up $10 in 3 months without an approval. It never came back down, even when the the FDA decision letter was issued, as it was developing many more.
APPA looks like it could do the same. This approval will initially bring shock waves and the stock will get up to $4 in a week. But with the revenue and partnerships to come the company will fill their pipeline with new drugs and be in a position to license their Biochronomer technology for hundreds of millions, not only upfront payments, but long terms royalties for many drugs in the future.
I am hoping it works out this time for everyone!
Anywone have any DD on why the company doesn't believe they needed to resubmit the NDA with a bioavailability study?
What decides if an Adcomm will take place for a specific drug?