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The FDA Gives Itself Room To Move On Amarin's Appeal
- This is no ordinary review process based entirely upon scientific considerations, but rather an upper level deliberation based upon the legal implications of agency decision making thus far.
- The latest FDA responses to citizen petitions and to Amarin's official appeal indicate that the agency might be struggling to give itself a little wiggle room to make concessions.
- Whilst only a few days ago I was deeply skeptical of John Jenkins' ANCHOR appeal response, I'm now cautiously optimistic that things might indeed move a bit in Amarin's favor.
- As a middle income, month-to-month investor, I'm loading up on Amarin shares because one day Vascepa will be approved in the ANCHOR indication and will be a multi-billion dollar drug.
Nektar Therapeutics Harnesses The Power Of AstraZeneca To Move Movantik
- Nektar, and Nektar shareholder excitement surrounding FDA approval of Movantik on the fast-approaching date of September 16th might only be exceeded by that of partner AstraZeneca.
- I told you back in January that AstraZeneca would flex its political influence at the OIC advisory committee meeting to effect a positive outcome. It's even better at product launches.
- Nektar president, Howard Robin was his usual understated self on the recently aired Q2 earnings call, reminding investors to be patient for a Movantik rollout following routine opioid antagonist de-scheduling.
Nektar President Howard Robin Is Listening To You
- Nektar will morph into a self-commercializing biopharmaceutical company within the next few years.
- Over the next six months, Nektar has more catalysts for stock price appreciation than any other biotechnology company.
- Of these value drivers: Movantik approval, BAX-855 phase 3 data and NKTR-102 (BEACON) data, an announcement by the company to market NKTR-102 themselves may be the biggest mover of all.
Nektar: Reason Will Rarely Fail You
- It's a stock with institutional ownership in excess of 93.5%, how then has Nektar lost 18.4% of its value since July 1st - especially given the positive OIC adcom vote?
- Rather than speculate about market manipulation or unreported news events, we'll take a logical approach to assess what has happened.
- Regado's halted REGULATE-PCI trial on July 2nd; Relistor label expansion into the opioid induced constipation population and Synergy's July 17th Phase 2 clinical trial enrollment completion factored into that equation.
- Regardless, this debris field of negativity will be washed away by a tidal wave of 2nd half catalysts that make Nektar one of the best long-term holds in biotech.
Amarin: Will The Lamb Of Ireland Bleat Or The Lion Of The People Roar?
- Amarin president, John Thero is hinting at mounting a 1st Amendment challenge to the FDA's off-label regulatory laws as a last resort, when he should be exercising free speech now.
- I'll show you how the FDA unjustly deprived Amarin of Vascepa expansion into the $40B high triglyceride indication and why everyone should care enough to do something about it.
- If Thero acts boldly, Vascepa could reach blockbuster status swiftly - paying for the completion of REDUCE-IT, financing all legal fees and rallying the stock to new heights.
- The FDA is counting on Thero's timidity and ignorance to complete the hobbling of the company by denying the ANCHOR appeal and rescinding the REDUCE-IT SPA when the time comes.
Regado's Revolixys Revolution Meets With Resistance
- Regado took a heavy hit to its reputation this past Wednesday evening. And Thursday morning's press conference was less hit than run.
- The stock was slaughtered on a half day of heavy trading, as investors misinterpreted what had really happened.
- If you bought the dip, you're now on an 8-week countdown to a return to fight or a technical knockout.
Placing Northwest Biotherapeutics In The Figure-4 Deadfall Trap
- The Figure-4 Deadfall Trap metaphor is useful in examining the flimsy sticks we use to prop up our investment thesis in any biotechnology stock, but especially those engulfed in controversy.
- There was a hidden sales message in the cascade of recent DCVax-Direct press releases, and investors bought it hook, line and sinker.
- Northwest Biotherapeutics has postponed DCVax-L trial completion dates, expanded and contracted estimated enrollment numbers, avoided updating actual patient participation statistics, and hinted at trial expansion.
- Instead of fighting progression-free survival (PFS) as a primary endpoint in the DCVax-L trial, I'll get you to see how it's an investment advantage, at least up until approval.
Regado Biosciences: The Revolixys Revolution Has Begun
- Regado Biosciences offers a paradigm-changing approach to acute cardiovascular care in the hospital environment tied to a multi-billion dollar commercial setting.
- On offer is an excellent short-term appreciative trade or long-term investment opportunity.
- Regado's late-stage product candidate, Revolixys Kit, is an advanced therapy that intends to standardize emergent catheter intervention procedures.
A Nektar Victory
- The now concluded FDA Advisory Committee Meeting on opioid induced constipation has Nektar positioned for rapid appreciation in the second half of this year.
- The September 16th Movantik PDUFA date is one of 5 major near-term catalysts. BAX-855 Topline Data; NKTR-181 P3 Trial Initiation; BAX-855 NDA Filing & NKTR-102 Topline Data being the rest.
- Movantik's $2B market opportunity will be the driving force behind the rebirth of AstraZeneca which may choose to forgo the $545M in future milestone payments by buying Nektar outright.
Cyclacel Shapes Sapacitabine's Phase IIb Study For Regulatory Success
- Cyclacel Pharmaceuticals is in the home stretch of a pivotal Phase III oncology trial that will serve to catalyze investor interest moving forward.
- Sapacitabine's safety profile and the passage of two DSMB reviews diminishes risk against what is already a disproportionately higher reward opportunity.
- A promising Phase IIb trial in R-MDS will enroll and read-out swiftly, providing new and rapid share price catalysts.
Cyclacel Pharmaceuticals: The Devil's Advocate Be Damned
- Cyclacel's big event to unveil the pathway forward for sapacitabine in R-MDS was disastrous to shareholder equity.
- Was any thought given to the consequences of engendering enormous expectations that would be met with underwhelming news? I hope not!
- Cyclacel's honored guest speaker at this invitation-only fiasco was Hagop Kantarjian, M.D., who was feisty, candid, bewildered and refreshing.
Celldex: The Race Leader In Glioblastoma Multiforme
- The best hope for a viable Glioblastoma Multiforme therapeutic improvement rests in the hands of these four teams: Celldex; CytRx; Nektar Therapeutics and Northwest Biotherapeutics.
- The two compounds with the best chance of winning the race to FDA approval are owned by companies with contrasting public images.
- Two remedies are targeted chemotherapeutics and two are immunotherapeutic.
The Incredible Cyclacel Pharmaceuticals
- An oncology company in phase 3, with orphan drug status, a Special Protocol Assessment agreement, and a market cap of $69m - Incredible!
- A confounding compound whose efficacy works in inverse proportion to the age of the patient benefiting from it - Incredible!
- A CEO twice diluting near 52-week lows, within days of hearing his CFO explaining why it wasn't necessary at the same 2 press conferences he's pontificating from - Not Credible!
Nektar Fortifies Its Position In Advance Of The Rescheduled FDA Panel On OIC
- Nektar's big event - the FDA panel on Opioid Induced Constipation, or OIC has been rescheduled for June 11th and 12th.
- An interim catalyst involving the readout of NKTR-171 Phase 1 data should keep shares solidly between $10 and $14 until naloxegol's future has been better defined.
- A small capital raise to hedge against the lesser possibility of FDA panel disappointment, and the strengthening of yet another partner's financial position, are positive developments since my last report.
The Stalled State Of MannKind
- The FDA has postponed MannKind's Afrezza PDUFA date until July 15, 2014.
- While regulatory assent seems likely, questions abound as to what form that approval will take.
- MannKind stock peaked in the wee hours of pre-market trading the day following a near unanimous adcom victory, but might not equal that fondly remembered price for years to come.
- Though talk of a buyout, or commercial partnership may satisfy the need to divert focus from the harsh reality of the present moment, neither is likely to occur soon.
MannKind's Latest Critic: The FDA Has Joined The Chorus Of Missing Data Concerns
- The historical foundation of the Afrezza application is made up of multiple identified deficiencies.
- Missing data is now a black box concern of the FDA as well.
- The seal of MannKind's fate will be broken on Tuesday, April 1, 2014.
MannKind: The Gambler's Creed - Let It Ride
- In my previous article, we examined the obstacles to approval that Mannkind faces at its upcoming FDA advisory committee meeting by expanding our definition of what an adcom is.
- In this article, we'll suss out the risks for long-term investors that attend to holding through this or any other high-profile event in the absence of using options.
- Are adcoms really approved 82% of the time as MannKind's fervent supporters suggest? I'll demonstrate why it's better to read a document with quiet discernment than with partisan zeal.
- And finally, we'll address the role that bloggers play in clarifying important issues surrounding investment in the sector, especially as this applies to binary events and to adcoms in particular.
Sunshine Heart: An Elementary Question Reveals A Profound Problem
- Sunshine Heart's Counter-HF pivotal phase 3 trial of their remarkable C-Pulse Heart assist system for Class III and IV heart failure patients is enrolling sluggishly at best.
- Investors should ignore the noise and laser focus on enrollment numbers moving forward.
- Criteria for enrollment might be too rigid, competition for patients too stiff and the device might work too well for patients to stay on the required 12 months of participation.
- The share price has been in steady downfall since a news release in mid-January of this year and short interest has been steadily rising.
- Most troubling of all, the stated goal of 4 years to completion of the Counter-HF trial may be flawed by design.
- Thank You For Riding The MannKind Catalyst Train - Please Exit Safely At The Next Available Station
- MediciNova: Gestation Is Slow And Uncomfortable - Birth Is Sudden And Unexpected
- Nektar Therapeutics Is The Seattle Genetics Of San Francisco But It Could Be More
- Cyclacel Rising
- Cyclacel Pharmaceuticals Preferred Shares: An Investigative Report
- The Captain Of Amarin's Listless Ship Makes Ready For The Storm
- With Or Without You Cyclacel Is Going To Rise
- Novavax: Big Pharma Wants RSV Bad
- The Explosive Biotech Calendar Catalyst Play: Novavax's 1st Analyst Day
- Synergy Pharmaceuticals: There's Strength In Safety
- Is Novavax On The Fast Track To Profits?
- Novavax Elevating To The Power Of 2
- Amarin's Anchor Will Hold As Vascepa's Sails Unfurl
- Hodgkin Lymphoma: The Top Secret Strategy Of Seattle Genetics Revealed