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Neuralstem, Inc. Message Board

mmbuddha 45 posts  |  Last Activity: Apr 10, 2014 11:29 PM Member since: Aug 10, 2006
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  • Reply to

    NSI-189 Phase 1b results...

    by jmssvnnhdsprs Apr 10, 2014 3:44 PM
    mmbuddha mmbuddha Apr 10, 2014 11:29 PM Flag

    It will never happen at this stage of the development of its pipeline...CUR would never agree to such a low ball offer by Big Pharma, unless the offer was for $5B or more ($60/share). Like I said, it will never happen at this stage. More likely after FDA approval of NSI-566 for ALS after BTD. JMHO,

  • Reply to

    Hi guy´s don´t worry be happy !!!!

    by investorgold Apr 10, 2014 10:16 AM
    mmbuddha mmbuddha Apr 10, 2014 10:19 AM Flag

    I think anyone holding for 1 year only will be pleasantly surprised. Phase II results will be out this year and BTD will be filed and acted upon early next year. If that happens, then 40 pps upon FDA approval. JMO,

  • mmbuddha by mmbuddha Apr 10, 2014 10:07 AM Flag

    For the most part, CUR cannot be responsible for what its patients want to reveal to the public about their progress. Therefore we have blogs and comments from some of the patients (April, Ted, John and others) of astounding results. It may be that, although the results so far are outstanding, CUR cannot be directly involved with the release of any actual public data during the Phase II trials (or comments about them) because that may be perceived by the FDA as "public campaigning" (or trying to "strong arm" the FDA) to push its stem cells before the trials are completed and all of the data is analyzed, and that could jeopardize an otherwise favorable FDA decision for BTD or AA, and, ultimately FDA approval.

  • Reply to

    April 9

    by market_ace Apr 9, 2014 3:20 PM
    mmbuddha mmbuddha Apr 9, 2014 11:16 PM Flag

    All I know, is that 2 analysts have mentioned BTD, one saying that it has already been filed and another saying that it will be filed this year. Regardless, as far as I know, management has made no public statements at all about filing for BTD, not even mentioning this as a possibility. While I would agree with you that a filing for BTD status will not be made until after Phase 2 trials are completed, at best, it would be interesting to know that indeed progress is being made to warrant such a filing with the FDA. For example, has management had any discussions with the FDA about such a filing? JMO,

  • Reply to

    trying to find some info

    by sighter8 Apr 9, 2014 6:08 PM
    mmbuddha mmbuddha Apr 9, 2014 6:17 PM Flag

    Looks like discussion is focused once again on safety.

  • Reply to

    April 9

    by market_ace Apr 9, 2014 3:20 PM
    mmbuddha mmbuddha Apr 9, 2014 3:23 PM Flag

    I will add to that wish list some official discussion from CUR management on direction of BTD for ALS treatment based upon ALS Phase II results so far.

  • Reply to

    Stock!

    by davecarmen48 Apr 7, 2014 8:16 PM
    mmbuddha mmbuddha Apr 8, 2014 2:44 PM Flag

    Recent job postings on their website seem to indicate some positive exchanges with the FDA.

  • mmbuddha mmbuddha Apr 8, 2014 1:12 PM Flag

    Believe me sir, I knew Joe Vish, and you, sir, are no Joe Vish...

  • Reply to

    Stock!

    by davecarmen48 Apr 7, 2014 8:16 PM
    mmbuddha mmbuddha Apr 8, 2014 10:26 AM Flag

    I am thinking 300-400 pps myself for largely the same reasons...plus, add to that the remarkably safe profile free from any side effects as well as its strong efficacy. 2-3 years is about right, imo.

  • Reply to

    Stock!

    by davecarmen48 Apr 7, 2014 8:16 PM
    mmbuddha mmbuddha Apr 8, 2014 9:51 AM Flag

    I think so. Average 3.58 Kerx with 7000 shares and in pre Peri fiasco too.

  • Reply to

    Stock!

    by davecarmen48 Apr 7, 2014 8:16 PM
    mmbuddha mmbuddha Apr 7, 2014 10:57 PM Flag

    Thanks, already bot some at 15.30 late fall of last year during the FDA fiasco. Just sitting and waiting now.

  • Reply to

    Moving with the IBB again

    by jbkenser Apr 4, 2014 11:24 AM
    mmbuddha mmbuddha Apr 4, 2014 11:35 AM Flag

    Break through designation and/or accelerated approval by the FDA, right to die legislation that is rapidly being approved by the states, and the continuous benefits being experienced by the ALS Phase 1 and 2 patients, and all that will change...quickly I might add.

  • "Wonderful. I'm doing great & thankful for every thing I've gained since surgery. Eating dinner then starting a new blog post"

  • Reply to

    How big is NSI-189...

    by charttrendzz Mar 30, 2014 4:10 PM
    mmbuddha mmbuddha Mar 30, 2014 5:43 PM Flag

    I may be wrong, but I don't believe Abilify nor Cymbalta has any off label use. OTOH, NSI-189 should have a huge market for anti-aging and/or smart drug use by patients that do not have any neurological condition. That market alone will make it a blockbuster drug.

  • Posted March 24, 2014, google: "FDA Releases New Accelerated Approval Labeling Guidance" for the article. Looks like CUR ALS treatment might qualify for AA. Here is an excerpt:

    "Under Section 506(c) of the Federal Food, Drug and Cosmetic Act (FD&C Act), accelerated approval is reserved for products intended to treat or cure a "serious or life-threatening condition" based on surrogate endpoints that are "reasonably likely to predict clinical benefit."

    For example, if a drug is intended to treat a deadly type of cancer and early data indicate that it has slowed the progression of the disease, it could be eligible for accelerated approval.

    In addition to the severity of the disease, FDA is also supposed to take into account its rarity as well as the availability (or lack thereof) of alternative treatments. If ample FDA-approved treatments are already available, a new drug is unlikely to obtain accelerated approval unless it demonstrates a marked improvement in safety or efficacy relative to the existing treatments—a "meaningful advantage over available therapy."

    It's also important to note that drugs approved through the accelerated approval pathway are given somewhat tentative approvals. "Approval under this section will be subject to the requirement that the applicant study the drug further, to verify and describe its clinical benefit, where there is uncertainty as to the relation of the surrogate endpoint to clinical benefit, or of the observed clinical benefit to ultimate outcome," explains 21 CFR 314.510.

    Drugs may be withdrawn if they fail to show subsequent benefit, or they may be granted full and unconditional approval."

  • Reply to

    Almost Time - Let's Speculate

    by red_bull_sa Mar 25, 2014 7:56 PM
    mmbuddha mmbuddha Mar 25, 2014 9:48 PM Flag

    1. 6-8 is likely initially, with a possible move to 10.
    2. Not going to happen, but if it were to happen, then 1-2 is likely.
    3. No.
    4. I am not sure they will be able to argue the negatives if it establishes very good effectiveness for ALS patients -- it is too groundbreaking, imo.
    5. Too early for that extrapolation. Market only factors in coming to market with products now. BTD will expedite that for ALS and this BTD will start to be priced in soon after Phase II results if positive.
    6. All depends on the nature and extent of effectiveness for Phase II ALS patients. I think they will hold off on filing for BTD until after all Phase II patients have been treated and all initial data is known, late this fall or winter.

    Agree wholeheartedly with your last paragraph.

    GLTU

  • From the SRPT message board: "The IBB is getting destroyed because of news related to GILD. The majority of biotechs are taking a beating today. SRPT is no exception." May explain in part today's price action in CUR.

  • mmbuddha by mmbuddha Mar 21, 2014 9:56 AM Flag

    Looks like MM's cleaned out the stops, imo.

  • mmbuddha by mmbuddha Mar 20, 2014 3:02 PM Flag

    Anyone else seeing a connection between today's price movement and the info scheduled to be released at Dr. Feldman's Phase II ALS presentation set for 4/9?

  • Reply to

    So whats the news today to kick coal

    by sitkadidit Mar 20, 2014 8:58 AM
    mmbuddha mmbuddha Mar 20, 2014 9:07 AM Flag

    wlt news?

CUR
3.79+0.01(+0.26%)Apr 17 4:00 PMEDT

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