For those that say there is no chance of approval...
I am just wondering, on this site I see a lot of "no chance" "little chance" concerning DRRX drugs. For those that make these claims, what are your credentials? Are you a doctor, work for the FDA, even in the medical field? It seems like a very out of your element statement to make unless you have experience in the Rx field. For those that make these claims could you please state your knowledge base in the field of medicine so we know if your full of it or not. Because unless you work for the FDA (in which case these statements would be illegal) how do you have any idea if their drugs will pass testing.
CUPERTINO, Calif., Jan. 5, 2012 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today top-line results from the U.S. pivotal Phase III clinical study for POSIDUR® known as BESST (Bupivacaine Effectiveness and Safety in SABER trial). POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented SABER™ technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery."
The Phase III trail did not fail for POSIDUR. The acceptance of this NDA by the FDA also implies that the DRRX technology is not the issue with Remoxy. PFE will likely continue the studies and remit the application to the FDA. Right now it wants to renegotiate the terms of the contracts. I don't think PFE will get much of a break in royalties from DRRX because of a minor change in its planned manufacturing process. The FDA is pushing for Remoxy but PFE is dragging its feet on these programs. They are doing the same thing with ACUR.
We can also look forward to the announcement of a partnership near-term. This stock should trade well over $1 . It also looks like a only nuisance trader kept down the price.
the Phase III trial for Posidur failed. now, they are trying to pull some slight of hand to say "yeah but look at our Phase II trails". Sorry, doesn't work that way. CRL coming and more dilution coming. Pfizer will also give back Remoxy as Oxy is now generic
"Dr" Brown is really a just a vet who should be doing pet wellness exams, not running a drug company
"Pfizer will also give back Remoxy as Oxy is now generic " You are also misinformed here. The FDA recently announced that it will not accept anymore generic OXY ANDAs, it also stated that it is in favor of the development of abuse deterrent or tamper-resistant opioids .
PCRX has a similar drug to POSIDUR on the the market for post op patients. The market has placed pretty good value on it too. DRRX should see an increase in value as a result of POSIDUR in the next 6 to 12 months. Part of the risk has been reduced by the FDA acceptance of NDA. Another factor to consider is that a similar product was already approved by the FDA, this increases the chances of approval for POSIDUR. Looking at it, POSIDUR is worth a least $4 a share on approval and a easy $1.5 leading up to approval which leave very little downside at these prices. PCRX is valued at almost $1 billion with a similar drug on the market.
The Phase III trial did not fail for POSIDUR. The acceptance of this NDA by the FDA also implies that the DRRX technology is not the issue with Remoxy. PFE will likely continue the studies and (resubmit) the application to the FDA. edit