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Galena Biopharma, Inc. Message Board

rocketjock1 28 posts  |  Last Activity: May 23, 2016 11:01 AM Member since: Mar 9, 1998
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  • rocketjock1 rocketjock1 May 23, 2016 11:01 AM Flag

    Thank you for the informative post.

    Sentiment: Hold

  • rocketjock1 by rocketjock1 May 22, 2016 5:28 PM Flag

    The stock seems really expensive with a projected growth rate of just 12 per year and a P/E over 93.

    Sentiment: Strong Sell

  • Reply to

    IDMC and early stopping of clinical trials

    by jayrouse913 May 21, 2016 11:36 AM
    rocketjock1 rocketjock1 May 21, 2016 1:35 PM Flag

    The important thing is that the company does not make a decision that jeopardizes approval of the BLA. If they abide by the SPA and trial results meet the agreed to criteria then approval is highly likely. If they stop the trial early then they have to be absolutely certain that they'll be able to provide all the data to address the FDAs concerns. I think the biggest question that may be left unanswered by an early stop is "Are the boosters providing a sustained longterm positive immunological effect or does it wane at some point?". If Galena stops the trial then everything is riding on that decision...if they cannot satisfy the FDA then there will be no going back...at least for Galena as we know it.

    Personally, I would rather wait out the next two years and be virtually guaranteed approval via the SPA. I'm not worried about financing the next two years of remaining trial time. Neuvax is proving itself with every passing day and if it working well enough to even consider an early stop then its working well enough to attract a big pharma partner to keep the trial going a couple more years.

    Sentiment: Strong Buy

  • Reply to

    IDMC and Efficac ---2

    by joenobody02 Apr 22, 2016 11:02 PM
    rocketjock1 rocketjock1 May 20, 2016 8:44 PM Flag

    I'd like to make a few points. First, I want to clear up what this document is. It is the Clinical Study Protocol for the PRESENT trial - it is not the SPA. It may contain some language regarding how the study will comply with the regulatory requirements of the SPA but the primary purpose is to define the specific events and activities that will be monitored during the study. I originally found this document on the Aptiv website and reposted to my own (rocketbusinessandfinance). Aptiv Solutions is the CRO that is responsible for providing the clinical management of this trial. You will notice that the document is signed only by representatives of Galena, Aptiv and MDACC. There is no FDA signature on this document as you would expect to see on the SPA so please accept it for what it is - just good information about how the trial is to be conducted. But, please do not feel that we can decipher the exact nature of SPA contents from it.
    Beyond the fact that I found the document and made it available for everyone to peruse, I claim no special insights into the meaning of certain statements contained within it. So, my interpretation is no more credible than anyone else's. My opinion, based on what I see in the document, and assessed alongside statements made by the company and associates like Dr Peoples, is that there is no specified efficacy criteria for an early stop to the trial. My interpretation of page 107 (and elsewhere) is that the "planned" use for efficacy data will be only for determining futility at the first analysis triggered by the 70th event (Hazard Ratio greater than 90% (i.e. recurrence reduction less than 10% from CG) and then again at the second analysis which is triggered by the 139th event or three years. Success is indicated by an HR over 62 at the 139th event (recurrence reduction of 38% from CG). However, the IDMC can always recommend actions to the sponsor if they see something extraordinary but only the sponsor can decide to stop the trial.

    Sentiment: Strong Buy

  • Reply to

    Still loosing money

    by riverfront418 May 3, 2016 2:35 PM
    rocketjock1 rocketjock1 May 6, 2016 3:50 PM Flag

    I don't expect the revenue picture to improve until this time next year. That assumes that they get approval for the 3 times per week Glatopa. The hype on their Humira generic should start to get them some attention too.

    Sentiment: Hold

  • Reply to

    Help with Lawsuit Rosen Law Firm

    by chaseyourdream_82 Apr 11, 2016 3:39 PM
    rocketjock1 rocketjock1 Apr 12, 2016 12:00 AM Flag

    No. If you held your shares beyond the end of the class action period (August 12, 2014) but your purchase price minus $2.77 is greater than zero then you still have a loss.

    Sentiment: Strong Buy

  • Reply to

    Help with Lawsuit Rosen Law Firm

    by chaseyourdream_82 Apr 11, 2016 3:39 PM
    rocketjock1 rocketjock1 Apr 11, 2016 9:58 PM Flag

    Me too. I had to call my old 401k broker to get copies of my statements for the class action time period. Once I had those it took about 4 hours to fill out claims for two accounts. I only have a few thousand shares that I bought over $2 (bought in mid $3 range) but that still may net me $500 @ .17 per share compensation.

    Sentiment: Strong Buy

  • Reply to

    Help with Lawsuit Rosen Law Firm

    by chaseyourdream_82 Apr 11, 2016 3:39 PM
    rocketjock1 rocketjock1 Apr 11, 2016 9:45 PM Flag

    The final determination will be depend on your losses in proportion to the losses of other claimants. The initial estimate is that the average recovery will be about .17 per share. If the difference between your buy and sale price (if you did sell) is higher than the average claimants then you will get more than .17 cents. If you didn't buy shares high (like me) and sold them not much lower than you purchased them for (or didn't sell) then you will get less than .17 cents.

    Part of your share of the recovery will be in the form of shares (1/20th of your loss determination).

    Sentiment: Strong Buy

  • Reply to

    Dr. Joe Comment Regarding Two PH3 Trials...

    by gene4346 Apr 6, 2016 9:42 AM
    rocketjock1 rocketjock1 Apr 6, 2016 10:23 AM Flag

    Most definitely.

    Sentiment: Strong Buy

  • Reply to

    Dr. Joe Comment Regarding Two PH3 Trials...

    by gene4346 Apr 6, 2016 9:42 AM
    rocketjock1 rocketjock1 Apr 6, 2016 10:17 AM Flag

    I haven't researched this yet but I question his assertion that "most" drugs require multiple phase 3 trials (planned). I have not seen that any of drug trials that I've followed. My experience has been that additional ph3 trials are done only if the sponsor determines additional data is needed once the first trial completes or is stopped or if the FDA issues a CR in response to a NDA or BLA that requires a new trial. Maybe he was speaking of immunotherapy trials specifically where there hasn't been as much research, but again, I don't know of any trials where two ph3 were planned.

    Sentiment: Strong Buy

  • Reply to

    Dr. Joe Comment Regarding Two PH3 Trials...

    by gene4346 Apr 6, 2016 9:42 AM
    rocketjock1 rocketjock1 Apr 6, 2016 9:58 AM Flag

    The SPA requires a recurrence reduction of at least 38% (Hazard Ratio of .62). This is stated in the Clinical Study Protocol and was confirmed by Dr Peoples during our discussion with him last week.

    Sentiment: Strong Buy

  • Reply to

    I Think We Are Headed For $2.00

    by jimkolak Apr 4, 2016 2:06 PM
    rocketjock1 rocketjock1 Apr 4, 2016 2:36 PM Flag

    Yep, $2 soon. I think $2 is still good value for new investors who may think they missed out. True value for this stock is mid-teens and I expect we are headed there by the end of Summer as the interim report is published followed by the phase 2 Neuvax/Herceptins interim data in September. See my rNPV analysis.

    Sentiment: Strong Buy

  • Reply to

    Dr. Joseph Sinkule Conference Call

    by danindenver33 Apr 1, 2016 7:02 PM
    rocketjock1 rocketjock1 Apr 1, 2016 8:28 PM Flag

    Hi Dan -Thanks for everything you've done to help inform the Galena investment community. You've done an absolutely amazing service for all of by bringing in these knowledgeable speakers. I'm really looking forward to listening to Dr Sinkule discuss the development of Neuvax under Apthera. I know as holders of many warrants, the Apthera team still has big stake in the success of Neuvax.

    Sentiment: Strong Buy

  • Reply to

    A rNPV analysis for Galena

    by rocketjock1 Jan 11, 2016 11:37 PM
    rocketjock1 rocketjock1 Apr 1, 2016 10:51 AM Flag

    Yes, someday ๐Ÿ™‚. But an rNPV analysis is used to determine how much you should be willing to pay for a stock today...not after its product has already been approved and has been bringing in revenue.

    Sentiment: Strong Buy

  • rocketjock1 rocketjock1 Mar 31, 2016 10:12 PM Flag

    You're right, all of the warrants may not be exercised but I expect most of them will be. I think the investors that bought the share offering in January are not looking for a long-term investment and would be more in favor of a quick profit rather than taking on risk. They can sell the warrants at $1.49 for a quick 5% profit. If we reach the $1.49 level in the next couple of weeks this represents an annualized 20% return for those investors. I think they'll take the money and invest again in another company desperate for financing where they can get good terms.

    Sentiment: Strong Buy

  • rocketjock1 rocketjock1 Mar 31, 2016 10:03 PM Flag

    I was going to wait until after the Interim report comes out in June before revisiting the rNPV but I might do it sooner. There were some suggestions for improvement left on the other thread that I may incorporate into it next time.

    I agree that I left out the remaining Q1 burn for March and I also forgot the one-time charge of $4-5 mil expected in Q2. I still think the $15 mil that will be reimbursed to Galena via the B&O is going toward settlement of the Class Action and that's why I didn't include it.

    Sentiment: Strong Buy

  • For those worried about the company having to raise cash again later this year the situation is not so dire. The offering in January included warrants totaling 13,643,181 that are executable at $1.42. We will begin to see these redeemed as the stock price extends above that price. When all these warrants are redeemed, Galena will have another $19.37 million in cash. Also, now that the stock price is over $1 the Lincoln Financing deal is available which will allow the company to raise up to another $42 million in cash.

    38.2 Million cash on hand as of Feb 29 - ~14 mil burn in Q1 leaves 24.2 mil at March 31st. 24.2 + 19.37 +42 = 85.57 cash available for operations.

    At their forecasted burn rate of ~8 to 10 mil/quarter for remainder of year, this amounts to over 9 quarters of cash available. There is also the potential for the company to earn revenue from the milestone payments arranged as part of the Zuplenz/Abstral divestiture.

    Sentiment: Strong Buy

  • Reply to

    Any technical analyst out there?

    by jdpali Mar 30, 2016 12:27 PM
    rocketjock1 rocketjock1 Mar 30, 2016 12:43 PM Flag

    The warrants from the January public offering become executable at $1.42 so expect some resistance at that level.

    Sentiment: Strong Buy

  • rocketjock1 rocketjock1 Mar 24, 2016 3:27 PM Flag

    No risk no reward. Galena saw the potential that no one else saw and got the rights to develop and market Neuvax cheap. Those of us that have believed will be rewarded too.

    Sentiment: Strong Buy

  • Reply to

    Partnership

    by jimkolak Feb 22, 2016 12:43 PM
    rocketjock1 rocketjock1 Mar 11, 2016 6:03 PM Flag

    Yes. Especially since Galena is on the hook to pay MDACC a 5% royalty.

    Sentiment: Strong Buy

GALE
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