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From Start-Ups to Large Cap. If I don't like it, I don't invest - but never short. Vigilante against pumpers making money off the backs of retail investors who trust their money down the toilet.
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  • Why Galena Failed Breast Cancer With A Terrible FDA Protocol 3 comments
    Mar 19, 2014 8:23 PM | about stocks: GALE

    Writing a great protocol is the most important start to any biotechs success.

    I think when people say "long-shot" they are really looking at the possibility of this ever making it to market. If it does, the market cap of GALE today exceeds the revenue potential thereof. Neither Ahn or Kriegsman seem to be moral/ethical philanthropists and their presence will forever stain the definitely needed secondary offerings to come.

    Yet, clearly NeuVax actually is 100% affective. Unfortunately, the population for this truth is a minority of a very small minority. Possibly as low as 1/100?

    NeuVax is a distant idea in this era of science. It was gifted to Ahn by Kriegsman for a small sum and BOD post for reasons I suspect are as corrupt as the dynamic duo have displayed in recent months. Companies like California Stem Cells, OxiGene (OXGN), and to a far lesser extent Northwest Bio (NASDAQ:NWBO) are light years ahead of this science. That of course being the 1 to 1 vaccine/treatment. These other companies, basing their science on current revelations rather than those from 2000, are likely to overcome any achievements made by Galena in a similar time-frame.

    Lastly, had Ahn/Kriegsman, been able to write and seek approval based on achievable protocols, they would benefit from greater FDA throughput. Instead, Galena sought an out of range target, leaving their studies, outcomes, and data in need of a great deal of interpretation. They needed to shoot with perfect aim at a small target. Instead they shot blindly at a wall. Although NeuVax was 100% affective in the population I mentioned, their protocol was not assessed to achieve that singular aim. A better protocol would not appear to be so suspect, as the target would be finite and the study results immaculate. It would not require a 700 person 8 year off study completion either.

    If their primary target was that micro-population, they would already be moving forward with a Ph3 under a SPA, with no controversy over the appearance they "massaged" results. Ahn COULD have a great victory, a breakthrough with patients waiting for their chance. Instead - they needed to convince the FDA the target they bullseye'd should be re-aligned into a Ph3 SPA. Ahn was frantically trying to negotiate a way forward - it turned into a get rich quick scheme with a secondary offering and near guaranteed financial failure as a result of cash burn and lack of trust going forward. Now - also under extreme pressure from dozens of scandals. They should be in a position to run towards and receive FDA approval based on their data. Unfortunately, that data is not in line with their previously defined route to approval. a 700 person, 8 years at best hurdle ahead....

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

    Additional disclosure: Like Ahn, Kriegsman has a terrible reputation for writing achievable protocols. There are several very competent large-scale CRO's who have been fired for completing the mission these 2 CEO's sought. The only true failure was their arrogance, and inability to incorporate constructive criticism into their protocol goals.

    Stocks: GALE
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Comments (3)
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  • chongkim74
    , contributor
    Comments (1719) | Send Message
    Did you read the article about how the US military synthesized Neuvax base and let Gale develop and license it? Interesting article showing the efficiency and credibility of it.
    26 Mar 2014, 05:18 PM Reply Like
  • chongkim74
    , contributor
    Comments (1719) | Send Message
    I must say you have some interesting info, I can verify with. Appreciate the info for whatever ur initiative maybe. Happy hunting.
    26 Mar 2014, 05:33 PM Reply Like
  • jackryanjr
    , contributor
    Comments (153) | Send Message
    Author’s reply » Apthera was the originator of NeuVax, and the ENTIRE COMPANY was purchased for $6-7 million AFTER completing the Ph2 clinical trials.


    Apthera changed to RXi who changed to Galena who changed to Galena & RXi.


    I don't particularly EVER like Adam F. Articles, and he is often wrong in the world of BioTech because he thinks they all are terrible until they receive an NDA. This article, page 3 mostly, says a lot of the things I am saying - he just does it without explaining the terrible way by which these companies attempted to write protocols for FDA approval.


    Lastly, what it's really about is that in science, you do a few things for ANY experiment.
    State the end result you hope to achieve.
    Test your idea by experimenting.
    Analyze your results.
    Report if results support the original idea you hoped to achieve.


    NeuVax fails this. Although there are SOME seemingly positive results, they do not in any way support the planned end-point. In this case, it is who the target patient is supposed to be. The drug works for HER2- or HER2 mild presentations, while it was aimed at HER2 Highly Expressed, Middle, & Low.


    This is something akin to being attacked by 2 bears and shooting at them. You miss both, but kill a wolf that was waiting to eat the leftovers of the bear attacks. You still can't claim after the fact that you planned to scare away the 2 bears with noise while aiming to hit the wolf lurking out of site.
    26 Mar 2014, 06:54 PM Reply Like
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