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Sanofi Message Board

scistats 308 posts  |  Last Activity: 8 hours ago Member since: Apr 5, 2009
  • 3.4.4. - irinotecan - Orphan - EMEA/H/C/004125
    Baxter Innovations GmbH;
    treatment of pancreatic cancer
    Scope: Letter from the applicant dated 15
    April 2016 requesting extension of clock stop to
    respond to the Day 180 list of outstanding issues adopted on 25.02.2016
    Action: For adoption by written procedure
    List of Outstanding Issues adopted on 25.02.2016. List of Questions adopted on 24.09.2015.

    Sentiment: Strong Buy

  • Reply to

    Wow, Stemcentrx was indeed a little MACK

    by scistats Apr 28, 2016 9:29 AM
    scistats scistats Apr 28, 2016 9:31 AM Flag

    1. ditto
    2. ditto
    3. ditto

    it was "little MACK"

    Sentiment: Strong Buy

  • Wow, Stemcentrx was a little MACK.

    Directly from Stemcentrx's webiste:
    1. "we engineer and manufacture antibodies and antibody drug conjugates for those targets."
    2. "Stemcentrx combines state-of-the-art research and GMP manufacturing capabilities. "
    3. "We are also developing companion diagnostic tests that can be used to identify patients most likely to benefit from those drugs."

    Sentiment: Strong Buy

  • Reply to

    Hey Scistats

    by innsbrooklad Apr 28, 2016 8:42 AM
    scistats scistats Apr 28, 2016 9:09 AM Flag

    Inns, do you know what the technology is that Stemcentrx is using?

    First of all, lower the price tag. AbbVie said it would pay about $2 billion in cash and fund the remaining with stock with a lot of "maybe's". Obviously Stemcentrx was willing to give its "blockbuster" technology.

    Lets see what Stemcentrx has:

    1. Rova-T: Rova-T is an antibody drug conjugate that is made to target DLL3, enter the tumor cells and release a potent drug to kill these cells.

    2. SC-002 is another antibody drug conjugate in development for small cell lung cancer.

    3. SC-003 is an antibody drug conjugate in development for ovarian cancer.

    Hmmm, sounds like the same stale technology. And yes, I am familiar with CRISPR, but we live in the here and now.

    Sentiment: Strong Buy

  • scistats scistats Apr 27, 2016 10:41 PM Flag

    I don't know what decisions you had rather the CEO have made? A small biotech cannot go in every direction at once. MM-121 partnership offers may have been too low to mess with after Sanofi.

    Antibodies, targeted chemo, manufacturing, and diagnostics is a full plate for little MACK. If you add on checkpoint inhibitors, vaccines, and listeria, it is impossible. Everybody has a niche and role to play. We just have to see that each of the MACK business segments makes money. Targeted chemo (MM-398/Onivyde) is on track and will always have a niche. MM-141 and others look good, but we could obviously use a checkpoint inhibitor or vaccine partner.

    I am not sure what you mean by Onivyde did not getting approval, MM-398/Onivyde is approved?

    Oncology therapy today is more fragmented than ever. Merrimack is setting itself up as an antibody company, including manufacturing of antibody conjugated to liposomes. These antibodies will not stand alone only with chemo. They will be tied to immuno therapy at some point. But, putting them out one by one will not be profitable. I see MACK selling out as a plug and play antibody resource that will dovetail nicely with some big pharma's immuno program. I think there is an end game here.

    I am in at 9 PPS now, but had opportunity like everyone else to get out with profit but chose to let EU approval and other developments play out. We shall see.

    Sentiment: Strong Buy

  • scistats scistats Apr 27, 2016 12:53 PM Flag

    Oh, and generally agree with your PPS target following earnings, with big emphasis on "what we hear".

    Sentiment: Strong Buy

  • scistats scistats Apr 27, 2016 12:51 PM Flag

    Italian, if you do not mind sharing, how did you vote on the proxy?
    1. I agree it may be a natural time for leader change and see CFO mentoring for CEO. He is older than Zuckerberg who, the last time I heard, is doing pretty good.
    2. Approve on advisory basis executive compensation, voting no would really mean what? They reconsider?
    3. PWC is ok.
    Thanks in advance.

    Sentiment: Strong Buy

  • scistats scistats Apr 27, 2016 9:11 AM Flag

    Also, the recent hiring of Yasir B. Al-Wakeel as CFO and potential future CEO was not a bad move.

    "Yasir B. Al-Wakeel, BM BCh, has served as our Chief Financial Officer and Head of Corporate Development since August 2015. Dr. Al-Wakeel previously served in various capacities at Credit Suisse, an investment banking firm, from January 2008 to June 2015. While at Credit Suisse, Dr. Al-Wakeel was most recently a Director of Healthcare Investment Banking focused on biotechnology and, prior to that role, he was an Equity Research Analyst covering the biotechnology and specialty pharmaceuticals sectors. Before joining Credit Suisse, Dr. Al-Wakeel was a practicing physician, holding both clinical and academic medical posts. Dr. Al-Wakeel holds a BM BCh (Doctor of Medicine) from Oxford University, an M.A. in theology from Cambridge University and a B.A. from Cambridge University."

    Sentiment: Strong Buy

  • Naysayers: "Mack could have partnered and or been sold by now probably ten times over..."

    Sold what ten times over?

    MM-093 and MM-111 were dispatched.

    MM-121 is part of a therapy for only a fraction of patients for which Sanofi is not interested, despite Novartis backing this exact same approach with their own LJM716 (that also inhibits HER3, albeit behind in development relative to MM-121). Sanofi wants a big drug that captures everyone and makes big money. MM-121 will require companion diagnostics in collaboration with Leica to determine which patients MM-121 works for (i.e., have the ligand heregulin (HRG). Then, you still have to combine MM-121 with other therapeutics for the strategy to work. If MM-121 is only part of a treatment for part of the patient population, how many times can you slice and dice it before there is no more profit left to be had? I guess Merrimack could partner it and find out.

    Also, MM-398 (Onivyde) was partnered, and there is still $422.2 million remaining to date in the Baxalta deal. Not too bad. We should see some more of this cash in a few days with EU approval and EU sales milestones, both of which are on record for payouts to Merrimack.

    Only now is Merrimack coming in to its own with with broadly viable antibody candidates like MM-141, MM-151, targeted liposomes, liposome and antibody manufacturing services, and a diagnostic/imaging business that is starting to create a true buyout or major partnership target.

    Sentiment: Strong Buy

  • scistats scistats Apr 26, 2016 6:18 PM Flag

    You need anger management counseling.
    Flipping one bad CEO for another is not going to solve the problem.
    You will be just as angry with the next guy, if not more.
    Mulroy has 4 million shares. I think he probably want to move the PPS north too.
    What if the PPS goes up on a MM-302 or MM-141 deal?
    Are you at least satisfied with Dr. Al-Wakeel?
    Would you be happy with him as CEO and a good deal or two?
    If so, I think both of these thing will happen. Al-Wakeel is an MD with management skills in pharma. And Mulroy had something to do with getting him on board.
    So, while I agree the PPS is not where we want to be, it could be easily if things fall into place.

    Sentiment: Strong Buy

  • scistats scistats Apr 26, 2016 5:35 PM Flag

    Ok, let me write these down, stock sucks but why, will Mulroy leave, inns (hater), sheep theft.
    Got it!

  • scistats scistats Apr 26, 2016 3:40 PM Flag

    Please add to the list if you have any questions.
    I will email them in tomorrow.

    Sentiment: Strong Buy

  • scistats scistats Apr 26, 2016 3:38 PM Flag

    What is the total 'Onivyde estate' income projection stated by Mr. Mulroy for Q1 2016?

    Sentiment: Strong Buy

  • Reply to

    Ohhh, the shark babe, has such teeth, dear,

    by baldobaboy Apr 26, 2016 12:38 PM
    scistats scistats Apr 26, 2016 1:09 PM Flag

    Afraid of the water?
    RNk7XRWp4GE

    Sentiment: Strong Buy

  • scistats scistats Apr 26, 2016 12:06 PM Flag

    13. Is PROVYDE™ (ONIVYDE® Access Services) going to expand into a business of its own to provide patient assistance outside of Merrimack therapies? A patient reimbursement business affiliate of Merrimack to address pharmaceutical costs and affordability?

    Sentiment: Strong Buy

  • scistats scistats Apr 26, 2016 11:59 AM Flag

    11. Merrimack is working toward localizing cancer through imaging technology such as described in United States Patent Application 20160106672 liposome...or imaging entity. And clinical trial NCT01770353 which is in Expansion Phase: The expansion will enroll patients with advanced metastatic breast cancer into three cohorts. When do you see Merrimack imaging going to the market, and what is the market potential here, or is this simply imaging support for Merrimack therapeutics?

    12. Likewise, is the Leica diagnostic deal for pairing with therapeutics only or a profit making venture into selling technology to pair personalized medicine? Help us separate companion diagnostics and genotyping assisting therapy vs. a business of its own.

    Sentiment: Strong Buy

  • MACK 1st Quarter 2016 Conference Call at 4:30 p.m. ET, Monday, May 2nd.
    The call will cover an update on Merrimack's progress as well as a summary of 1st quarter 2016 financials. A press release detailing the information to be discussed on the call will be issued the afternoon of Monday, May 2nd. A listen-only webcast of the call will be available in the Investors section of Merrimack's website.

    Questions:

    1. What do MM-161 and MM-436 target?

    2. When will the EU approve Onivdye?
    Committee for Medicinal Products for Human Use (CHMP) Meeting Dates:
    25-28 April?
    23-26 May?
    20-23 June?
    18-21 July?

    3. Is $422.2 million remaining to date in Baxalta deal? If so, when do we get it, and how much for EU approval and sales milestones in the EU?

    4. Are Onivyde sales for Q1 between $8 million and $12 million?

    5. Is the agreement with Allergan where Merrimack will utilize its proprietary nanoliposomal technology platform to develop and manufacture various pharmaceutical products for Allergan still active?

    6. Is MM-302 and MM-310 going to be partnered with Baxalta/Shire as an extension of next-generation Onivyde, antibody-targeted nanoliposomes.

    7. Data for MM-141 (istiratumab) plus chemo looks good. Will it also be partnered with a checkpoint inhibitor?

    8. Could the Aduro listeria platform match any MACK technology for a future partnership?

    9. Are there any new nanoliposome or antibody manufacturing contracts, and if not, is manufacturing still viable for MACK? If not, will this unit be relocated or sold?

    10. Silvercreek appears to be circling the drain....what say you about this "asset"?

    Sentiment: Strong Buy

  • Reply to

    March sales?

    by dchance75702 Apr 25, 2016 3:52 PM
    scistats scistats Apr 25, 2016 6:28 PM Flag

    Yes, they will PROVYDE™ the numbers next week.

    Sentiment: Strong Buy

  • Reply to

    Bottom-bottom, where's the bottom?

    by baldobaboy Apr 25, 2016 2:45 PM
    scistats scistats Apr 25, 2016 3:24 PM Flag

    Hey, PennyStock101 has the most profitable stock picks i've ever come across. They picked MACK, so I did too! I guess though, now that you mention it, I did not really think about the bottom. That's scary. Maybe MACK does not have a bottom, like that Tom Petty song. But when I think of MACK, I guess I am much more positive.

    Sentiment: Strong Buy

  • scistats scistats Apr 25, 2016 12:14 PM Flag

    PROVYDE
    can help by offering:
    •Benefit verifications
    •Prior authorization (PA) support
    •Claims and appeals support
    • Financial assistance for eligible
    patients,* including:
    - Patient assistance program (PAP) for uninsured or
    functionally uninsured patients

    - $0 copay assistance for commercially
    insured patients
    - Referral to independent, nonprofit organizations
    °
    Cost-share assistance for state or publicly
    insured patients (eg, Medicare)
    °
    Transportation assistance

    Sentiment: Strong Buy

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