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Grand Canyon Education, Inc. Message Board

greg_m_thornton 9 posts  |  Last Activity: Oct 21, 2015 7:32 PM Member since: Sep 14, 2009
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  • greg_m_thornton greg_m_thornton Oct 21, 2015 7:32 PM Flag

    Idiot this is a "boxed warning" label not just your typical warning label like you see on your Nytol.

    Since you seem to have no clue here is a description of what a boxed warning label is from Wikipedia:

    In the United States, a boxed warning (sometimes 'black box warning', colloquially) is a type of warning that appears on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text.[1] The FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.[2] [3]

  • greg_m_thornton greg_m_thornton Oct 21, 2015 7:27 PM Flag

    I really suggest you read the Adam Feuerstein article again. Everyone was already expecting that this drug would get approval today. The approval is not news. The key was whether or not they would get a clean label. Unfortunately, for RLYP they did NOT get a clean label. Everyone was worried that without a clean label they would have troubles with their commercial launch. They will burn through that $200M in cash in no time trying to launch and sell this drug, and then without a clean label they are going to have a hard time getting revenues as high as they would like. Hence the stock price will suffer. If RLYP goes up at all tomorrow I will view it as a gift and will fade and perhaps even short the rally.

  • Sorry longs but it looks like RLYP will drop some on this news. Everyone already new they would get FDA approval. That is already priced into the stock. What they don't know is how well the commercial launch will go. Investors were hoping for a "clean label" which would have sent the stock price higher, but instead they got a boxed warning label which is horrible news for the launch

    Here are the quotes from recent TheStreet article by Adam Feuerstein indicating the key was getting a clean label....

    "Investors, generally, see small risk that FDA rejects patiromer Wednesday but they're also taking a cautious attitude towards the drug's commercial launch.

    "We recognize that the patiromer commercial launch requires us to build the market and educate doctors" about a new way to treat hyperkalemia, said Relypsa's Arnold.

    The outlook for patiromer's commercial launch will be helped if FDA approves the drug with a clean label, including approvals for both acute and chronic treatment of hyperkalemia with no significant warnings or restrictions. Relypsa also hopes FDA allows once-daily dosing of patiromer."

  • Reply to

    My guess it will be halted until morning

    by avenger_18 Oct 21, 2015 6:03 PM
    greg_m_thornton greg_m_thornton Oct 21, 2015 6:38 PM Flag

    IF the company is worried about stock going down then they will keep it halted until tomorrow so they have time to have a phone conference with investors and try to put a positive spin on it. On the other hand if the company thinks it is great news they will lift the halt as soon as possible and let it trade higher. So far not a good sign that it is still halted.

  • What is everyone's guess at what price RLYP will open at and when will it open fpr trading again?

    If the company thinks this is good news then they should remove the halt and let it trade soon.

    My guess is that it opens at around $16 a share. Why little change? The news is mixed. They did get approval so that is a big plus. But it came with a box warning and limited the target population and that is a minus. Also, Biotechs are struggling right now and even with good news things tend to pop then fall back.

    So if there is a big pop up I will short it as I would guess it comes back down soon. On the other hand, if there is a big sell off then I am a buyer as the box warning isn't the end of the word. If it stays at $16 it is fairly priced and I will move onto other opportunities..

  • Wow nice pop into the close today. What a rally. Perhaps it is time to not only get out of this stock but go short. It appears to be a strong "dead cat" bounce today and perhaps should be shorted?

  • greg_m_thornton by greg_m_thornton Oct 1, 2015 4:18 PM Flag

    Rumor has it, phase 3 results could be out as early as tomorrow morning. Should be exciting either way

  • Reply to

    why how

    by lordie8888 Oct 1, 2015 4:07 PM
    greg_m_thornton greg_m_thornton Oct 1, 2015 4:16 PM Flag

    I had the same question... But it does seems to be dropping back down some in the after hours

  • Wow does anyone know why AXON rocketed up from 14% down to 8% up the close today. That is a 22% jump for apparently no reason. Wow that is really some volatility. Scary!

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