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Sanofi Message Board

biotech_invest 99 posts  |  Last Activity: Apr 23, 2015 12:38 PM Member since: Mar 5, 1998
  • Continuous Glucose Monitoring (CGM) is an FDA-approved device that provides real-time glucose readings, throughout the day and night, allowing people with diabetes to see their glucose levels and track how quickly they're increasing or decreasing. CGM has been an established technology since 2006 and performance advances throughout the years have made today’s systems increasingly accurate. A typical CGM provides up to as many as 288 glucose readings per day (once every 5 minutes).
    In simple words diabetics that have CGM device can see Afrezza action in real time i.e. how blood glucose level behaves after combination of meal + Afrezza or meal + injection of meal-time insulin.

    Sentiment: Strong Buy

  • biotech_invest biotech_invest Mar 12, 2015 12:56 PM Flag

    Nope, I never short biotechs with such low pps :-) May be even will buy 5-10k at low (like $1-1.10). If Prana management is not stupid they will remove FDA hold for phase III HD trial without animal studies (I'll give 30% probability to such scenario) and PRAN pps can spike to $2-3 range. Worst case scenario (2 years animal neurotoxicity studies) will drop PRAN pps to $0.70-0.75.
    So. $3k losses (for 10k shares) in worst case scenario and $10-15k for best one. May be I'll play this game.

  • There 4 examples of scummiest biotech in my list:
    PRAN Institutional Ownership 01.47%
    CTIX Institutional Ownership 0%
    ORMP Institutional Ownership 16.57%
    NNVC Institutional Ownership 09.58%
    I always was wondering how funds/institutions know that some biotechs are scams and never buy them (or buy very small number of shares).
    Look at PRAN: this small cap biotech is claiming that their drugs (PBT series) can cure such incurable diseases as Alzheimer, Huntington's disease, Parkinson's disease and etc. They even had phase II trials for AD and HD and have claimed phase II HD trial as successful. But funds/institutions are still don't buy it.
    At the same time some YMB PRAN pumpers rumor that Big Pharmas are already in line and want to acquire PRAN for $10 or even higher per share. Other pumpers are infinitely citing scientific papers that "support" Prana idea that metal chelators can cure practically everything. But funds are still skeptical and highest position is 159,348 shares of PRAN

    KCG HOLDINGS, INC. 12/31/2014 159,348 143,146 883.51 183
    GARRISON BRADFORD & ASSOCIATES INC 12/31/2014 109,842 (16,500) (13.06) 126
    FRIGATE VENTURES LP 12/31/2014 108,681 108,681 New 125
    SUSQUEHANNA INTERNATIONAL GROUP, LLP 12/31/2014 95,491 (106,400) (52.7) 110
    OXFORD ASSET MANAGEMENT 12/31/2014 81,649 81,649 New 94
    BANK OF AMERICA CORP /DE/ 12/31/2014 72,000 30,000 71.43 83

    Conclusion: retail investors (especially newbie) should always check % of Institutional Ownership in small cap biotechs before investing. Biotechs with 0 or with few % are mostly scams and there is very high probability of huge losses.

  • They have tried to mislead MNKD investors with false predictions of annual sales of Afrezza but who will believe that at least 10% of diabetic patients will never try new inhalable meal-time insulin with extremely fast PK/PD?
    In Israel and Europe diabetics have possibility to monitor blood glucose without needles: this device is called GlucoTrack, and it offers the ability to test blood sugars without having to poke our fingers or draw any blood. All we need to do is put a clip on our earlobe. Well, this isn't actually new; the product's been in development by Israeli company Integrity Applications and in 2013 GlucoTrack finally secured CE Mark approval to sell in Europe, and now hopes to submit the device to U.S. regulators as soon as possible -- with a plan to conduct clinical studies here sometime this year. The GlucoTrack DF-F model is a high-tech earlobe clip that measures glucose using three kinds of technologies: ultrasound, electromagnetic, and thermal. You just clip the GlucoTrack sensor onto your earlobe and within a minute, it sends your BG data through a headphone-style cord to a smartphone-sized handheld controller. And that's where the glucose reading is displayed or even verbally announced.
    By using GlucoTrack diabetics will compare Afrezza PD with any marketable injectable meal-time insulin and they will see very big difference.

    Sentiment: Strong Buy

  • biotech_invest biotech_invest Mar 10, 2015 5:21 PM Flag

    again you are wrong here: I have used PRAN run up for both HD/AD trial and got very good profit. But they I shorted PRAN and got profit again when pps was crashed from $11 to $2. Everybody can check my posts and see that I was never wrong about PRAN (see below).
    About current situation: I like to play with scam biotechs like PRAN but it should be very specific time frame for such risky game. Right now I don't see any good opportunity to have significant profit with PRAN. I have scam biotechs in my list and just wait for right moment. Now it's moment for EMIS.

    08/23/13: PRAN is hot, runup is started - will buy more but sell before October (too high risk to keep it through AD trial results release)

    01/31/14: it's time to sell small caps or even short them - market correction starts now. Shorted PRAN it's universal AD/HD drug is doomed

  • biotech_invest biotech_invest Mar 10, 2015 5:04 PM Flag

    actually FDA hold is on higher daily doses of PBT2 (more than 250 mg daily). 250 mg daily was proven to be safe for both HD and AD patients.
    PRAN management wants to persuade FDA to allow higher doses of PBT2 (like 250 mg twice per day) because they know that 250 mg daily is not effective for both HD and AD.

  • biotech_invest biotech_invest Mar 10, 2015 4:50 PM Flag

    kad, are you delusional? when I was wrong about PRAN? When I posted these posts in advance of AD trial results release?

    biotech_invest • Feb 7, 2014 10:44 AM
    PRAN is doomed
    PBT2 can't be both HD and AD drug (because these diseases have absolutely different mechanisms i.e. etiologies). Looks like PBT2 will not cure both diseases but at the same times it's safe enough for not to stop trials. Monitoring doctors will never see difference in HD and AD during the trial if drug is useless - they only stop trial when treated group conditions become worse (patients have brain inflammations like with Elan drug or just died like with LLY secretase inhibitor). So my predictions: both HD and AD trials will fail on efficacy but safety will be OK.
    Sell PRAN now or your losses will be giant (pps Less
    Sentiment: Strong Sell

    Or this one?

    biotech_invest • Mar 19, 2014 2:10 PM
    how about $2.4 after AD trial results release?
    PRAN has nothing more in pipeline so 80% down in pps is very realistic scenario (I remember the terrible crash of LJPC after lupus trial termination in 2009: 90% down to $0.26). Well, LJPC survived this crash but some investors were not.
    Sentiment: Strong Sell

    Or may be this one:

    biotech_invest • Mar 27, 2014 5:36 PM
    I'm always serious. I have shorted positions for 2 fake biotechs: PRAN and ORMP. Both companies just fool naive investors. Look at PBT2 chemical structure - this simple organic molecule can't cure such complicate diseases as HD and AD.
    All PRAN believers will know truth next week Monday - Tanzi fooled them all and become millionaire. Less
    Sentiment: Strong Sell

  • Indeed, Prana management can remove FDA hold via very simple movement: agree with PBT2 dosing 250 mg per day in phase III HD trial. Phase III HD initiation may drive PRAN pps to $3 range for short time but then pps will again decay to $2 (HD phase III will take 2-3 years). So short-term reward for PRAN (if you bought at $1.15) can be 100-150%.
    But if PRAN say that they will do animal toxicity studies we will see pps drop below $1 (most likely to $0.7-0.8) for next 1-2 years. PRAN management will have their good salaries for 2 more years and since they don't care about PRAN investors they will prefer longer way to phase III trial.
    Since SILENCE of the Prana is too long, variant #2 (animal tox studies) is most probable and PRAN holders will have losses 20-30% (if they bought PRAN at $1.15).
    The majority of PRAN pumpers on MB bought PRAN at high so they are desperate, want to persuade new investors to buy PRAN and start some "run up". So PRAN losers will have some opportunity to compensate their losses.

  • Increased Positions 95 17,367,831
    Decreased Positions 68 7,159,492
    Held Positions 46 76,992,798
    Total Institutional Shares 209 101,520,121

    Previous number was 91M

    It doesn't look like utter detestation. Mann has almost 180M + funds have 101M = almost 300M shares from Total Shares Outstanding 409M. It looks like very deep but hidden love to MNKD. At some point Mann/funds will have 350M and then real MNKD pps will be revealed. But it will be too late for "weak hands" that are selling MNKD now.

    Sentiment: Strong Buy

  • shorts know it but use low prescription numbers for FIRST month when Afrezza become available (since 02/03/15). Logic is simple here: low number of prescription will scare MNKD longs and force them to sell MNKD shares with losses. Sanofi reps also know about this 3-month delay for diabetes patients so they use this time for visiting doctors and give them samples. Doctors will give these free samples to patients that currently use injectable meal-time insulin and explain how Afrezza works. Actually diabetics can use both forms of insulin and compare their efficacy via glucose blood testing.
    Afrezza needs some time to win market and main reason is that there are several meal-time insulins are already on market and diabetics are currently use them. 3 month supply was already paid by insurance companies and they will not pay for additional meal-time insulin that overlap with this 3 months supply.
    It's main reason for so-called "soft" start of Afrezza.
    Shorts and GS need to cover 86M positions during these 3 months and they will do everything to keep MNKD pps as low as possible.
    But look at growing % of funds/institutions holdings:

    Institutional Ownership 24.83%
    Increased Positions 17,367,831
    Decreased Positions 7,159,492
    Held Positions 76,992,798
    Total Institutional Shares 101,520,121

    VANGUARD GROUP INC 12/31/2014 15,214,948 493,961 3.36 90,377
    BLACKROCK FUND ADVISORS 12/31/2014 10,778,022 695,481 6.90 64,021
    FMR LLC 12/31/2014 9,214,968 0 0.00 54,737
    GREYWOLF CAPITAL MANAGEMENT LP 12/31/2014 7,206,570 1,000,000 16.11 42,807
    STATE STREET CORP 12/31/2014 6,941,132 1,034,533 17.52 41,230
    BARCLAYS GLOBAL INVESTORS UK HOLDINGS LTD 12/31/2014 6,620,978 184,809 2.87 39,329
    NORTHERN TRUST CORP 12/31/2014 2,583,098 5,543 .22 15,344
    BANK OF AMERICA CORP /DE/ 12/31/2014 2,359,560 1,232,059 109.27 14,016
    CREATIVE PLANNING 12/31/2014 2,028,080 18,850 .94 12,047
    SUSQUEHANNA INTERNATIONAL GROUP, LLP 12/31/2014 1,933,153 1,615,086 507.78 11,483

    Sentiment: Strong Buy

  • Reply to

    Info on the TauRx Rember Trial

    by interestingtome Mar 3, 2015 4:21 PM
    biotech_invest biotech_invest Mar 4, 2015 2:14 PM Flag

    If tau-based etiology of AD is correct we should see some breakthrough in AD curing.
    For example, recently published study showed that "as compared to healthy patients and ones with dementia caused by other conditions, those with both Alzheimer’s and Parkinson’s had seven times higher levels of the tau protein. People with Parkinson’s also had an eight times higher level of alpha-synuclein protein than the healthy control group."
    May be this new test will help not only for AD diagnosis but also for AD drug efficacy monitoring (more convenient than CSF test).
    TauRx is privately held biotech and investors were wanted less expensive clinical trials so may be it's main reason of absence of tau and p-tau monitoring. If ADAS-Cog and other cognitive tests show improvement or even slowing of AD progression TauRx will be a huge winner. Most important that their success will crash this stupid amyloid-only paradigm in AD area. Big Pharmas already spent hundreds million dollars on fighting with brain amyloid burden and got nothing.

  • Reply to

    Info on the TauRx Rember Trial

    by interestingtome Mar 3, 2015 4:21 PM
    biotech_invest biotech_invest Mar 4, 2015 12:22 PM Flag

    here I should agree: it will be better if TauRx monitor both tau and p-tau in both treated and control arms. Rember was claimed as an inhibitor of tau aggregation and since only p-tau presents in aggregates it will be interesting to know how treatment change CSF p-tau (most likely it must go up higher in treated arm than in comparator arm). Any way we will know very soon how tau-based medication works for AD (may be end of 2015). FDA doesn't care about AD markers like tau, p-tau and Aβ42 changes in CSF i.e. they are care only about ADAS-Cog and other cognitive tests results.
    I'm not very optimistic about future Rember results but definitely this "p-tau aggregation inhibitor" approach is smarter than BACE inhibitors, anti-amyloid antibodies and other. Time will tell.

  • other drugs that need faster PK/PD profile and convenient path of delivery. Sanofi already has preference rights for inhalable GLP-1 program and other Big Pharmas may pay big upfronts for designing of inhalable rapid-acting migraine drugs, pain killers and etc.

    Sentiment: Strong Buy

  • I was always thinking that Karp (Tourbillon Capital Partners) was just a decoy but real player and designer of short trading pattern is hiding in a shadow. Now we know Kingpin's name: Goldman Sachs Group, Inc. Looks like they have opened biggest short positions in MNKD and now they have finally admit it by SELL and $3 price target. GS wants to cover before MNKD pps will irreversibly go up so they have used everything to scare retail investors and force them to SELL MNKD shares below $6
    If GS and their cronies average short price was $9-10 and number is 30-40M they will make a huge profit by covering below $6 ( $100M). They know that funds and Mann that together have 65% of outstanding shares will never sell so the target is retail investors that bought 86M shorted shares (since August 2014).
    GS and his cronies know that Europe approval of Afrezza is coming, also licensing in China and India (+ 250M of diabetes patients).
    So, spooked longs that are selling MNKD now help GS to get a huge profit.

    Sentiment: Strong Buy

  • Citations:
    "CLINICAL STUDIES — Approval of Afrezza was based on
    2 unpublished clinical studies which are summarized
    in the package insert. The fi rst trial randomized 344
    adults with uncontrolled type 1 diabetes to mealtime
    doses of inhaled insulin or SC injections of insulin
    aspart, both in combination with basal insulin.
    After 24 weeks, the mean reduction in HbA1c with
    inhaled insulin was NONINFERIOR to the reduction with
    insulin aspart (-0.21% vs. -0.40%; the prespecifi ed
    noninferiority margin was 0.4%). The percentage of
    patients who achieved an HbA1c ≤7% was 27.1% with
    insulin aspart and 13.8% with inhaled insulin.
    The second trial included 479 adults with type 2
    diabetes that was inadequately controlled despite
    treatment with metformin alone or ≥2 oral antidiabetic
    drugs. Patients were randomized to inhaled insulin
    or placebo; both groups received stable doses of oral
    antidiabetic drugs. After 24 weeks, patients using
    inhaled insulin had a SIGNIFICANTLY GREATER mean
    reduction in HbA1c than those on placebo (-0.82% vs.
    -0.42%) and the percentage of patients who achieved
    an HbA1c ≤7% was 32.2% with inhaled insulin and
    15.3% with placebo.
    A 52-week, open-label trial enrolled 677 patients
    with type 2 diabetes that was inadequately controlled
    despite insulin therapy with or without oral antidiabetic
    drugs; patients were randomized to receive inhaled
    insulin plus bedtime insulin glargine or twice-daily
    biaspart insulin, a premixed SC insulin containing 70%
    insulin aspart protamine suspension (similar to NPH
    insulin) and 30% insulin aspart. The mean reduction in
    HbA1c in the inhaled insulin group was NONINFERIOR to
    that in the biaspart insulin group (-0.68% vs -0.76%).

    So for type I diabetes Afrezza is NONINFERIOR and for type II diabetes INFERIOR and NONINFERIOR

    CONCLUSION — Afrezza, the only inhaled formulation
    of insulin currently available in the US, appears to be
    only modestly effective in reducing HbA1c. Cough is
    a common side effect and the long-term...

    Sentiment: Strong Buy

  • it's 35% of MNKD float (or almost 20% of outstanding). Funds/institutions have 25% and Mann Holding has almost 40% i.e. altogether 65% of outstanding.
    We know that shorts can borrow shares (even from retail investors) and sell them to short. But who are the buyers? For example shorts borrowed 6-7M MNKD shares last time and increased short interest from 80M to 86M and average price of shorted shares was $7. Buyers of these 6-7M shares will keep them for a gain or can sell on market if they are scared by sudden drop of price (from $7 to $6). Shorts tactics is simple: sell short big volume, then scare buyers and force them to sell their positions with losses (some of the buyers can't resist even 5-10% price drop).
    So, I understand why shorts were shorting MNKD at $10-11 range after price spikes. It was easy to drop MNKD pps by selling 40-60M shares per several days of August. But why now? $7 looks like a stable bottom for MNKD that have cash, future milestone up to $750M, future Europe approval, new applications of Technosphere technology, 35% royalties from Afrezza sales and etc. I mean current buyers of shorted shares will keep MNKD tight and never sell positions even at $6. Now risk/reward is very favorable for long-term investment in MNKD: any positive events and good sales will drive pps to $10-15 but "no news" and "slow prescription rate" can only decay MNKD pps to $6.
    Bashers like Adam F. predict that Sanofi new CEO can cancel a deal with MNKD in 2015 but it's just idiotic and stupid idea: nobody will pay $150M upfront for nothing. Sanofi knows that Afrezza and other applications of Technosphere will be very profitable.

    Sentiment: Strong Buy

  • MNKD has enough cash now to avoid any stock dilutions and initiate clinical trials for inhalable GLP-1 and migraine drugs. If they collaborate with CARA and make their lead pain killer peptide inhalable (now IV only) with bioavailability 50% it will be breakthrough in anti-pain non-abusive therapy.
    Funds/institutions are increasing their stakes in MNKD but they are doing it silently: now they have 25% outstanding and other 45% in Mann holding. Retail investors have other 30% that were shorted. So who will sell MNKD shares to shorts when they will be forced to cover 80M short interest?
    Even HOLD and WAIT tactics will burn shorts, BUY and STRONG BUY will force them to file bankruptcy.

    Sentiment: Strong Buy

  • biotech_invest biotech_invest Feb 18, 2015 5:24 PM Flag

    I agreed, an initiation of phase III is very complicate process. Problem is in this FDA statement:
    "The FDA has provided Prana with options to remove the Partial Clinical Hold. To support moving forward with clinical trials of PBT2 at a clinically relevant dosage in humans, Prana would conduct additional animal neurotoxicity studies or identify a strategy for safety using a clinically relevant dosage in humans in the planned phase 3 trial in HD. The FDA has not raised any concerns about PBT2 safety data in human trials conducted to date."
    In simple words Prana can remove the Partial Clinical Hold via 3 methods: 1) agree to dose HD patients with 250 mg PBT2 daily (but this dose is not considered clinically relevant by Prana) - they can do it right now and FDA will remove PCH tomorrow ; 2) conduct additional animal studies (will take at least 1-2 years); 3) identify a strategy for safety using a clinically relevant dosage in humans in the planned phase 3 trial in HD. The last approach is most complicate because Prana did human safety trials for 800 mg PBT2 but only for 7 days i.e. it's not enough long study. Last time for HD PBT2
    250mg capsules was administered orally once per day for 26 weeks. FDA must be sure that 500-800 mg daily is a safe dosage and patients will not die during trial.
    Once again, the silence of Prana is most likely means that they will proceed with #2 (animal neurotoxicity studies) and PRAN pps will crashed to $0.8 for a long time.

  • They can remove FDA Hold any time by simple agreement to dose HD patients with PBT2 250 mg daily and initiate phase III during this or next month. But since they keep silence they choose another variant: 1-2 years animal toxicity studies.
    So what we have here: 1) initiation of phase III HD that will drive PRAN pps to $2-3 range (at least 100% gain for run up); 2) initiation of animal toxicity studies - PRAN pps will go below $1 for 1-2 years i.e, dead money for 1-2 years.
    I think that PRAN management will choose #2 because they know that PBT2 250 mg daily is not very effective for HD and phase III trial will fail. Phase III failure will kill PRAN: no money, fake drug for AD/HD. Animal studies are not very expensive and at least management will have their salaries 2 more years.
    Any way, we will know their decision during next couple weeks.

  • Now we have VVUS market cap $296M. Is it equal to current total assets?
    And was is about Q4 revenue? Q3 was $33M so annual revenue can be around $100M?

    So, $200-250M total assets, $100M annual revenue and VVUS pps just $2.88 and MC $296M. It's very strange. Look like that pps should be around $5-6.

    "The company’s total revenues for the third quarter of 2014 came in at $33.9 million as compared to $27.4 million in the year-ago period. The third quarter 2014 revenues included $15.1 million of license and milestone revenues, $5.3 million of supply revenues and $1.1 million of royalty revenues related to its erectile dysfunction (ED) drug, Stendra (EU trade name: Spedra).

    Period Ending Dec 31, 2013
    Assets
    Current Assets
    Cash And Cash Equivalents 103,262
    Short Term Investments 240,024
    Net Receivables 12,214
    Inventory 48,503
    Other Current Assets 19,938
    Total Current Assets 423,941

    Sentiment: Strong Buy

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