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  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    You are correct that many phase 3 trials fail after apparently successful phase 2. However, in the case of Aerosurf we know that lucinactant is safe and effective because it is the active pharmaceutical in Surfaxin. The issue is whether the device can deliver sufficient amounts of lucinactant throughout the lung, As I mentioned earlier, this is more of an engineering than a drug development issue. Also, we know that the capillary aerosol generator drug device combination has been successful in lamb and pig models. All of this suggests to me that if it is established in phase 2b that adequate amounts of drug are delivered that the chances for a successful phase 3 following a successful phase 2b are much, much higher than for a new therapeutic entity. Obviously, nothing is for sure in biology.
    Oct 18, 2014. 06:23 PM | 4 Likes Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    Phase 2b will show proof of concept and, if successful, believe me that will move the stock. Why do you believe otherwise?
    Oct 17, 2014. 10:05 PM | 3 Likes Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    I can think of no greater insult than being likened to AF.
    Oct 17, 2014. 04:58 PM | 3 Likes Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    Take a look at a previous comment in this article. Is starts with Aerosurf is a paradigm -----
    Oct 17, 2014. 04:57 PM | Likes Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    Phillip Morris spent hundreds of millions of dollars on finding better ways to deliver nicotine and out of this came the capillary aerosol generator which is the core medical device technology of Aerosurf. Phillip Morris licensed this technology for medical use to DSCO. I think they are entitled to a small royalty. Ironic isn't it that Phillip Morris may contribute to one of the great advances in pulmonary medicine.
    Oct 17, 2014. 04:56 PM | 2 Likes Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    Just met with Repligen yesterday. Fundamental story gets better and better. Report out next week,.
    Oct 17, 2014. 04:52 PM | 1 Like Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    Aerosurf represents a paradigm shift in the practice of neonatology. The currently marketed animal surfactants and Surfaxin are given as liquid instillates that are administered by an endotracheal tube (intubation) directly into the lungs of a premature infant with respiratory distress syndrome or RDS. Through lessening surface tension in the lungs, surfactant makes it easier for a baby's lungs to expand and contract when used in conjunction with a mechanical ventilator. However, because of the considerable risks associated with intubation and mechanical ventilation, doctors will only give this treatment to babies with the most severe form of RDS.

    There are 360,000 preterm babies born each year and the youngest (23 to 26 weeks gestation) are almost always intubated, given a surfactant and put on a mechanical ventilator. This is about 45,000 babies. However, there are another 110,000 generally older babies (26 to 32 weeks gestational age) who are at risk of RDS that doctors are reluctant to treat in this way because of the risks associated with intubation and mechanical ventilation. They are usually given nasal continuous airway pressure (nCPAP). It essentially uses nose clips to administer air to the lungs and maintain positive pressure in the lungs to prevent them from collapsing during exhalation.

    While nCPAP is much safer, it cannot deliver surfactant to the babies’ lungs. This creates a dilemma for the neonatologist on whether to treat with intubation and mechanical ventilation or with nCPAP. This decision can affect life and death and long term morbidity for the baby. The “holy grail” for neonatologists would be to be able to give a surfactant along with nCPAP. This is the therapeutic target of Aerosurf

    Aerosurf has the potential to make DSCO an exceptional company. In valuing Aerosurf, I think that one should look at the experience of MedImmune and its first key drug Synagis. Aerosurf and Synagis have a great deal in common. Both address disease populations of about 100,000 US babies. Synagis was priced at about $7,500 similar to my projection for Aerosurf. Synagis went on to reach about $1 billion of sales and was the major reason that Astra Zeneca (AZN) paid $15 billion to acquire Medimmune. I am estimating sales of Aerosurf also could reach the $1 billion level in the 2022 or beyond period. This example drives home the ultimate potential for DSCO if Aerosurf is successfully developed.

    The development pathway for Aerosurf is long as for reasons explained in this report, I am estimating approval in late 2017 or 2018. However, I think that the promise of Aerosurf will add consistent value to the stock as the drug progresses through development to commercialization. Investors should keep in mind that the key active pharmaceutical ingredient in Aerosurf is the same as that in Surfaxin. Hence, we go into the phase II and III programs knowing that the drug contained in Aerosurf is safe and effective. The challenge is to show that it can be effectively and safely delivered in an aerosol form. It is more of an engineering challenge than a drug development challenge.
    Oct 17, 2014. 10:41 AM | 3 Likes Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    CAG stands for capillary aerosol generator. I parenthesized this in my report (CAG) and SA picked this up as a ticker symbol.
    Oct 17, 2014. 09:42 AM | Likes Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    CAG refers to capillary aerosol generator which is the medical device used in Aerosurf. i parenthesized CAG and SA picked this up as a ticker symbol.
    Oct 17, 2014. 09:36 AM | 1 Like Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    I have a website called SmithOnStocks which is subscriber based. This is my only source of revenues from my biotechnology research.
    Oct 17, 2014. 09:29 AM | Likes Like |Link to Comment
  • Discovery Laboratories: Collaboration With Battelle Is Validation Of Aerosurf's Potential By A Sophisticated Third Party [View article]
    No.
    Oct 17, 2014. 09:23 AM | 1 Like Like |Link to Comment
  • Northwest Bio's Latest Financing Abuses Its Shareholders: Is The Charade Over? [View article]
    Jim Cramer in an amazing interview bragged that he manipulated stocks as a hedge fund manager and urges all hedge fund managers to do so because it is fun and very profitable. In this interview, he said "What's important when you are in that hedge fund mode is to not be doing anything that is remotely truthful, because the truth is so against your view - it is important to create a new truth to develop a fiction," So Cramer in the case of NWBO would presumably try to divert attention from positive developments and get people to focus on innuendo and factually incorrect issues such as (1) the interim analysis of the phase 3 DCVax-L trial was negative when in fact the Chairman of the Data Monitoring Committee has said that no interim efficacy analysis has yet been performed, (2) the German hospital access early exemption is just compassionate use and something that any drug can easily get (same with UK), (3) there is something shady about the Cognate relationship even though NWBO would be bankrupt if Cognate would have insisted on cash for its services instead of accepting stock and (4) Linda Powers will lose several tens of millions of dollars if DCVax-L fails is running some kind of scam and is not committed to the success of NWBO. The full Cramer interview can be obtained by googling Jim Cramer stock manipulation or this link. http://bit.ly/1cGqb2Z
    Oct 10, 2014. 03:59 PM | 7 Likes Like |Link to Comment
  • Northwest Bio: The Data Monitoring Committee Addresses The Status Of The DCVax-L Trial [View article]
    Jim Cramer in an amazing interview bragged that he manipulated stocks as a hedge fund manager and urges all hedge fund managers to do so because it is fun and very profitable. In this interview, he said "What's important when you are in that hedge fund mode is to not be doing anything that is remotely truthful, because the truth is so against your view - it is important to create a new truth to develop a fiction," So Cramer in the case of NWBO would presumably try to divert attention from positive developments and get people to focus on innuendo and factually incorrect issues such as (1) the interim analysis of the phase 3 DCVax-L trial was negative when in fact it was not done (2) the German early exemption is just compassionate use and something that any drug can get (same with UK), (3) there is something shady about the Cognate relationship even though NWBO would be bankrupt if Cognate would have insisted on cash for its services instead of accepting stock and (4) Linda Powers who has several of tens of millions of dollars that will be lost if DCVax-L fails is running some kind of scam and is not committed to the success of NWBO. The full Cramer interview can be obtained by googling Jim Cramer stock manipulation or this link. http://bit.ly/1cGqb2Z
    Oct 10, 2014. 03:08 PM | 2 Likes Like |Link to Comment
  • Northwest Bio: The Data Monitoring Committee Addresses The Status Of The DCVax-L Trial [View article]
    Could you explain to me why the Germans would grant hospital exemption early access to a clinically meaningless drug?
    Oct 10, 2014. 08:49 AM | 3 Likes Like |Link to Comment
  • Chimerix: A Company Focused On Infectious Viral Diseases With Investment Characteristics Similar To Trius [View article]
    By the way, I went to a buy on May 21, 2014 a price of $14.22. However, this report was only distributed to subscribers. Here is the link. http://bit.ly/1rj2m6W
    Oct 9, 2014. 10:13 AM | Likes Like |Link to Comment
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