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Originally posted by Deaddog
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Dog, NPSP is an orphan drug producer. REPLACE for the treatment of a rare parathyroid disorder has just-reported positive Phase 3 results. Another drug, GATTEX for short bowel syndrome just received approval in Europe and is up for FDA decision (PDUFA) on September 28th. Look for news of any FDA advisory panel ahead of this. Up-to-date news generally appears on twitter.com (search box put in $NPSP.) Biorunup tweet there says, "8/28 FDA Gastro AdCom notice is out. No mention of $NPSP... Strange, they said they expected a panel, I thought this would be the one." Watch for a run up starting maybe in late July in anticipation of positive (or not) FDA decision. -
Appa
See Phoenix 7.
A.P. Pharmaceuticals
Basically they developed a polymer-based system for delivering a known drug, Granisetron, to combat nausea in chemotherapy. They submitted a NDA (new drug application) to the FDA in 2009 and it was not approved. Instead, they received the dreaded CRL (complete response lettter.)
From the website: "A.P. Pharma is a specialty pharmaceutical company developing pharmaceutical products using our proprietary BiochronomerTM polymer-based drug delivery technology. The Company’s primary focus is on its lead product candidate, APF530, which, during 2008, completed a pivotal Phase 3 clinical trial for the prevention of chemotherapy-induced nausea and vomiting (CINV). Results from that trial were announced in the third and fourth quarters of 2008. In May 2009, A.P. Pharma submitted an NDA for APF530 under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA's prior safety and efficacy findings for APF530's active ingredient, granisetron. A.P. Pharma received a Complete Response Letter on the APF530 NDA and is targeting the resubmission of the NDA in mid-2012."
Important APF530 Milestones as of March 2012 are listed in the PDF file here: http://appharma.com/PDFs/Corporate%2...rch%202012.pdf.
Yahoo Zoo Board, good explanation of the CRL:
"Delay does not mean 'future approval'. From the FDA Website: 'A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form. It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application. The adoption of complete response letters is one of the Agency’s commitments under the Prescription Drug User Fee Act (PDUFA).'
Complete response letters are issued only for applications that are not approved. The response deadline happened before the FDA could complete their review. We one can hope for is that the FDA will eventually approve APF530 but there is no assurance whatsoever this will happen. Personally, I feel AP Pharma's submission was not well presented nor complete. A thorough QT study should have been prepared and submitted along with application as company not surprised by this request given history of FDA. Evidently, the presentation and analysis was not up to FDA standards as evidenced by the FDA's request for a re-presentation and re-analysis of certain Phase 3 clinical trial data. The biggest risk (IMO) rests with the delivery system which completely surprised me given this is not the first time they have been before the FDA with this technology (APF112). Given the novelty of their delivery system, they should have anticipated questions, concerns, and discomfort from the review panel. Questions about the transfer process, certain components used in the dosing system and the potential for faulty administration in patients should have been addressed up front in their submission and in early conversations with the FDA. My interpretation of this is the FDA threw this NDA back into their laps and said clean this mess up and re-present the data in clear and understandable terms with appropriate documentation and analysis. There is much to be done and hopefully they will get their act together and win over the minds of the FDA. The submission was a screw up and time is now of the essence. I anxiously wait for an update regarding the status of the NDA."
to be continued.....Comment
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Appa (cont'd)
This company's (APPA) product reminds me of ALXA (Alexza Pharma). ALXA has an inhalation delivery system for a known and available med. Has had a difficult time getting FDA approval. In my early days of trading bios, I lost a boat-load of $$$ on ALXA. So I still have nightmares.
APPA has a polymer delivery system for a known and available med. Having difficult time getting FDA approval. Hmm... But it's a penny stock. I think P7 has bot the 17,500 shares sold so far today. I'm gonna wait till it gets back to its 0.16 52-WeekLow.Comment
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Amln
7:36 AM today: Bristol-Myers Squibb (BMY) and AstraZeneca (AZN) win the battle for Amylin (AMLN), agreeing to buy the diabetes drug maker for $31/share (10% premium to Friday's close). The total size of the deal is $7B, and includes about $3.4B from AZN which will expand its diabetes collaboration with Bristol. (from Seeking Alpha).
I have a GTC bid in now for sell @ 30.99. We'll see how that goes...
Billy, time to sell!
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Happy!
Happy Independence Day!!
Happy Canada Day!!Comment
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Sld AMLN 30.72, +14%.Originally posted by riverbabe View Post7:36 AM today: Bristol-Myers Squibb (BMY) and AstraZeneca (AZN) win the battle for Amylin (AMLN), agreeing to buy the diabetes drug maker for $31/share (10% premium to Friday's close). The total size of the deal is $7B, and includes about $3.4B from AZN which will expand its diabetes collaboration with Bristol. (from Seeking Alpha).
I have a GTC bid in now for sell @ 30.99. We'll see how that goes... Billy, time to sell!Comment
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River,
I can't find any comment of yours concerning PCYC. With a market cap of 4 billion it's not a Baby Biotech but Phoenix has got me very interested in it . Morpheus rates it at #2 in relative strength and the chart looks as if it's ready to bust out. Now a site called squeezetrigger.com says it's ripe for a 19% gain in the next 4 weeks. I value your opinion.
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billy, as you know, this stock has been on a tear this year. The chart looks great for a possible breakout. I haven't been following it because my $$$ have been tied up in AMRN. Looks to have a deep pipeline. Low volume today. Search twitter.com and/or stocktwits.com using $PCYC. Earnings 9/12. What's not to like for short term? GLTY! Wish I could trade it too.Originally posted by billyjoe View PostComment
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River, I've also got to free some $$. Maybe get rid of F after all these years. I think I could do better with the $$ than F is doing. Not a cuss word in this instance.
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River, I'm deep in biotech now. Sold F. Bought IBB and PCYC.
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I was hoping to buy your shares of F....I'm asking $9.30....guess you sold to someone else....Originally posted by billyjoe View Post
hagsComment
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Hags, I don't see F going much lower. You'll probably get a nice profit in the long run.Originally posted by hags View Post
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Dvax
I am in this one for a few $$ @ 4.23. VERY speculative. Looking for a run-up in pps going into FDA panel meeting Nov. 14-15. That's the only reason at this point. PDUFA in Feb. 2013, pretty far out for spec. on that. Not risking the farm here! Read all about it on Yahoo Finance. Both Mark Messier & Cramer like it, but remember they both work for thestreet.com. Another coin toss and extreme volatility. Will NOT be holding thru the panel meeting. Just hopefully taking a few $$ during the possible run-up ahead of it. No oinks. http://www.thestreet.com/story/11693...o&cm_ven=YAHOO
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Amarin
In @ 13.79, looking for 22-26+.
Waiting and waiting and waiting and waiting.... At this point there is a self-imposed news blackout at AMRN, cancelled latest presentation at biotech conference. Looks promising but who knows for sure? Betting the farm on this buyout. Otherwise sayonara. (Do as I say, not as I do...)
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