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VIVUS Inc. Message Board

atlnsider 71 posts  |  Last Activity: Jul 24, 2014 1:13 PM Member since: Dec 6, 2003
  • Reply to

    where's atl

    by cheating_stock_invester Jul 24, 2014 11:33 AM
    atlnsider atlnsider Jul 24, 2014 1:13 PM Flag

    I am still here. I am not going anywhere any time soon.

    I posted over the weekend under the message post "Hey ATLnsider", in response to the blog comments that were posted on The Motley Fool by zzlangerhans, but otherwise, I am content to wait & see what is disclosed during Alexza's Q2 earnings release & conference call on August 7th.

    Also, I have been communicating with Alexza IR regarding some questions & clarifications I had in connection with the Staccato System pipeline, but I have not learned anything new or significant thus far..

    I am always looking at other investment opportunities, but I haven't pulled the trigger on anything new lately. But, I will always continue to monitor the market for other opportunities. I wish I had owned of few shares of PBYI (Puma Biotechnology) before this week.

    Sentiment: Strong Buy

  • Reply to

    Hey ATLnsider

    by jab2478 Jul 19, 2014 4:54 PM
    atlnsider atlnsider Jul 20, 2014 12:27 AM Flag

    If Tony Friedman is the same as zzlangerhans, and he posted the blog comments on The Motley Fool website, then I am not concerned about his comments. I did read his comments, and I posted a response to his comments on The Motley Fool.

    I tweeted a link to my response @ATLnsider.

    However, the bottom line is; he does not believe that ER physicians, nurses, psychiatrists, and other healthcare providers will use Adasuve to treat bipolar & schizophrenic patients who are suffering from acute agitation. He believes that doctors will prefer to "tackle, restrain & forcibly inject patients". He is entitled to his opinion, but he had no facts to back up his opinion.

    He also believe that when Alexza report Q2 financial results on August 7th, the results will be disappointing. Again, he is entitled to his opinion. I do not know what Alexza will report on August 7th, but I believe & hope that the number of Adasuve units shipped to Teva & Grupo Ferrer will be significantly higher than what was reported for Q1.

    I am not looking for Alexza to report blockbuster numbers for Q2, but I am looking for a significant increase in Adasuve units shipped quarter-over-quarter.

    Investing is not an exact science, and it is not easy. If an investor does not believe that Adasuve will be a commercial success, then that investor should not invest in Alexza. The Q2 financial results will give all of us an indication of whether or not Adasuve sales are headed in the right direction.

    Sentiment: Strong Buy

  • atlnsider atlnsider Jul 16, 2014 5:57 PM Flag

    The only recent news I've seen is the fact that Teva has started the clinical trials to test the safety & efficacy of ADASUVE treating adolescents children between the ages of 10 to 17. Also, Alexza has started the same clinical trials in the EU. If the trials are successful, and if the safety & efficacy data supports it, the ADASUVE approved labels in the US & the Eu could be expanded to include treating adolescent children.

    However, this news may not be the primary reason for the recent uptrend. It look like a large institutional investor has been accumulating shares over the past few days.

    In addition, I am expecting Alexza to start the AZ-002 Phase 2 clinical trials any day now. I am also expecting Alexza to release Q2 numbers for ADASUVE units shipped to Teva & Grupo Ferrer. I hope that the Q2 numbers will show a significant increase from Q1.

    The only reasons you should double down on ALXA are:

    1. You have done your own extensive research & due diligence on Alexza & its Staccato system platform, and you believe in the fundamentals.

    2. You believe that Teva will do a good job commercializing ADASUVE in the US, and ADASUVE sales in the US will meet or exceed guidance.

    3. You believe in the long-term prospects of ADASUVE in the US & the EU, and the rest of the Grupo Ferrer territory.

    4. You believe that Alexza will be successful in globalizing ADASUVE sales in additional countries like: Canada, Australia, China, India, Japan, South Korea, the Middle East, and North Africa.

    5. You believe in the long-term prospects of Alexza's Staccato System platform, and Alexza's ability to successfully develop more drugs, like: Staccato alprazolam, Staccato fentanyl, etc.

    Sentiment: Strong Buy

  • Reply to

    How goes it Chumps??!! Tired yet?

    by kingscatss Jul 15, 2014 1:09 PM
    atlnsider atlnsider Jul 16, 2014 2:32 PM Flag

    Not really excited by day-to-day fluctuations in Alexza's stock price. Whether the stock price goes up or down. I am still waiting for at least 3X the current stock price.

    I am still waiting for ALXA to hit my target price of $16.28 per share and higher. The $16.28 target is just for ADASUVE in the US & the Grupo Ferre territories. It does not include ADASUVE sales in other territories like: Canada, China, India, Japan, Austrailia, Indonesia, Taiwan, Malaysia, the Middle East & North Africa.

    Nor does my target price of $16.28 include any other Staccato based drugs like Staccato alprazolam, Staccato fentanyl, etc.

    You are the one who gets really excited when Alexza's share price goes down, or it does not move much. I am very patient & I will wait to see where this goes...

    Sentiment: Strong Buy

  • Reply to

    How goes it Chumps??!! Tired yet?

    by kingscatss Jul 15, 2014 1:09 PM
    atlnsider atlnsider Jul 16, 2014 1:58 PM Flag

    Has anyone seen Kittycatss?

    Please keep him away from tall buildings & sharp objects!

    Sentiment: Strong Buy

  • Reply to

    How goes it Chumps??!! Tired yet?

    by kingscatss Jul 15, 2014 1:09 PM
    atlnsider atlnsider Jul 16, 2014 12:45 PM Flag

    Where's Kittycatss!!

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    If the safety & efficacy data is positive & supportive, the ADASUVE FDA approved label in the US could be modified & expanded to allow ADASUVE to be used to treat children & adolescents between the ages of 10 to 17. The trials will be conducted in Atlanta, GA & Cincinnati, OH.

    Also, the safety & efficacy data from these trials could be used to modify & reduce the current ADASUVE REMS requirements. The clinical trial data from these studies should be available by November 2014.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Teva continues to grow the brand awareness of ADASUVE among emergency room physicians & nurses across the US.

    Sentiment: Strong Buy

  • Reply to

    Which way will this go?

    by jab2478 Jul 2, 2014 1:25 PM
    atlnsider atlnsider Jul 2, 2014 2:33 PM Flag

    I agree with most of your points. I would add that the market & most analysts are not assigning much value to Alexza shares for the Grupo Ferrer deal anyway. Alexza negotiated the Ferrer deal when it was in a position of extreme weakness. The Ferrer royalties & milestone payments for Adasuve sales in the Ferrer territories are not very lucrative for Alexza.

    I also believe that the Teva uptake numbers for Adasuve are increasing. Alexza should be releasing Q2 updated shipment volumes for Adasuve in the US in early August. I am hoping for at least a doubling of the Q1 numbers.

    I am also hoping that Ferrer's number will show a material increase from Q1 numbers, especially considering that Adasuve was launched in Romania in March 2014, and in the Nordic countries (Sweden, Denmark, Norway & Finland) on April 30, 2014.

    I agree that Alexza does need to expand its Staccato pipeline beyond Adasuve. Staccato alprazolam is a start, but I would like to see more Staccato based drugs added to the pipeline this year. AZ-002 did fail to meet its endpoints for treating panic attacks, but I am hopeful that it will meet its endpoints to treat acute repetitive seizures (ARS).

    I am also hopeful that Alexza will be able to raise significant cash (millions of dollars) to fund future operations by signing new partnership agreements for expand Adasuve to non-US & non-Ferrer territories, such as: Canada, China, India, Australia, South Korea, Japan, the Middle East, and North Africa.

    Sentiment: Strong Buy

  • Reply to

    Any Thoughts on Mannkind getting Afrezza approval.

    by tnbioman Jun 28, 2014 9:35 AM
    atlnsider atlnsider Jun 30, 2014 7:27 PM Flag

    castleenterprises79 is correct; Afrezza was approved with a Box warning & a REMS.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    This is very good exposure for ADASUVE, with the people who will be the first line of treatment for schizophrenic & bipolar patients who are suffering from acute agitation.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider.

    There are 2 poster abstracts that will be presented by Alexza & Teva together. The first poster will present the post-approval ADASUVE study data for the effect of multiple doses of ADASUVE on QT prolongation or cardiac repolarization. The date concluded that no clinically relevant change in QTc was seen with multiple doses of inhaled loxapine in this population of healthy volunteers. Inhaled loxapine did not significantly prolong the QTc interval in this study.

    Hopefully, this data, and additional post-approval data will help support approval of an ADASUVE sNDA & label expansion to treat agitated patients with up to 2 doses of ADASUVE per day, instead of the current 1 dose per day. Also, this data could be used to help support FDA approval of ADASUVE label expansion to allow customers to use ADASUVE in-home, and not just in a hospital setting.

    The 2nd poster presents the ADASUVE post-approval data that studied the interaction of ADASUVE with IM Lorazepam to compare the pharmacodynamic effects and safety of single-dose inhaled loxapine
    plus intramuscular (IM) lorazepam versus each agent alone. The study concluded no effects on respiration or vital signs were seen for inhaled loxapine + IM lorazepam vs. each drug alone. There was greater sedation with IM lorazepam + inhaled loxapine compared with either drug administered alone in these
    healthy volunteers.

    Sentiment: Strong Buy

  • I tweeted the link to Alexza's presentation at the 2014 Epilepsy Pipeline Conference @ATLnsider.

    You can advance the video to the 2:57 mark to see Dr. James Cassela (Alexza's CSO) present the information about Staccato alprazolam (AZ-002) at the conference.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Teva continues to build its nationwide sales rep network to call on all major health care facilities that treat schizophrenia and/or bipolar patients who are suffering from acute agitation.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Hopefully, this is to meet increased demand for ADASUVE during Q2 2014 & beyond. Also, should help meet the demand of producing Staccato Alprazolam for clinical trials during 2014.

    Sentiment: Strong Buy

  • atlnsider atlnsider Jun 2, 2014 2:37 PM Flag

    I would add the following near-term catalysts (6 to 12 months):

    1. Continued roll-out & launch of ADASUVE in other EU countries (France, Italy, UK, etc.) & other non-EU Grupo Ferrer territories (Brazil, Mexico, etc.).

    2. Additional ADASUVE licensing partnership agreements in non-US & non.Ferrer territories, such as: Japan, South Korea, Taiwan, Malaysia, China, Indonesia, Canada, Australia, the Middle East & North Africa.

    3. Additional Staccato based drugs added to the pipeline, to go along with ADASUVE & Staccato alprazolam.

    4. Potential development partner(s) for Staccato alprazolam global opportunities.

    Sentiment: Strong Buy

  • Reply to

    Question about Process how the drug given.

    by tnbioman May 30, 2014 2:59 PM
    atlnsider atlnsider May 30, 2014 3:13 PM Flag

    ADASUVE is not intended for patients who are severely or violently agitated. It is intended to treat mild to moderate acute agitation for patients who are suffering from schizophrenia or bipolar I disorder. If a patient is lucid and cooperative enough to take an oral tablet, they are also lucid and cooperative enough to take ADASUVE.

    If a patient is violent, aggressive, or otherwise uncooperative, then they may have to be forcibly restrained and forcibly given an IM injection.

    The mild to moderate agitated patient is a fairly sizable market, and this is the label that ADASUVE was approved for.

    Sentiment: Strong Buy

  • atlnsider atlnsider May 30, 2014 12:17 PM Flag

    castleenterprises79;

    I agree with you. I have had augosto on "Ignore" for over a month now. That has worked very well for me.

    He seems to crave attention, and pretends like he has "inside information". He also pretends to speak bad English, so that he appears to be from outside the US.

    I believe that Alexza's stock price will go up significantly in the near-term on its own. No one has to make up any lies or untruths to try and help the process along.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    Alexza continues the globalization of ADASUVE. The pace will accelerate once Alexza signs new ADASUVE licensing & partnership deal in in non-USA & non-Ferrer territories.

    Sentiment: Strong Buy

  • I tweeted the link @ATLnsider

    It looks like the smart money, including: Institutional Investors + Mutual Fund Investors + Alexza Insiders, and some long-term retail investors are continuing to buy, accumulate, and hold ALXA shares.

    Sentiment: Strong Buy

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