With Share Offering Registration And Trial Enrollment Complete, Time To Buy MannKind [View article]
KLLJ, Yes, the window would be better defined by " prior to release of phase III" and, WCoast, yes, on actual sale of shares.
wCoast, share dilution, yes, but it brings cash in at whatever price they can sell the shares at, so I guess I would expect the lowest share price might be soon after an actual offering, not as much as the percentage dilution however.
I think trying to get in at the lowest price, based on new information, needs to be balanced with the possibility that optimism about approval and potential sales of Afrezza may rise, and share price accordingly.
Merck's Entry Into The Parkinson's Disease Drug Race [View article]
In your article, which investors should read (http://bit.ly/QfYmoK), you note that dipraglurant is being developed for Parkinson's disease levodopa-induced dyskinesia (PD-LID) whereas preladenant is being developed primarily for reducing off time, so the indications are different. The biggest question is whether either will be approved, then questions like co-administration arise. I don't know whether dyskinesia or off time are the most disconcerting problem with Levodopa therapy, which would get at your question on market share. In this article, it was noted that Adenosine A2A receptor antagonist, fipamezole, might reduce PD-LID. Importantly and should have been included in this article is that Kyowa Hakko Kirin's seeked approval for Istradefylline, which is also an Adenosine A2A receptor antagonist and received a not approvable letter from the FDA (http://prn.to/RRW2pi). Kyowa Hakko Kirin has completed a phase 3 trial in Japan demonstrating decreased off time and has submitted for approval in Japan (http://bit.ly/QmFMKF). This drug could be the first to market Adenosine A2A receptor antagonist, albeit in Japan. US rights for have been returned to Kyowa Hakko Kirin from Valeant (http://bit.ly/RRW2pk).
Vivus (VVUS) -6.2% premarket after Jefferies downgrades shares to Underperform, citing generic competition. While investors have been concerned about patents for the weight-loss drug Qsymia, the firm thinks doctors may choose to prescribe generics since branded Qsymia is unlikely to be covered by payors and the two generics will be more affordable for patients. [View news story]
Keep in mind, both drugs are formulated in lower doses in Qsymia than the already prescribed individual drugs. It is unlikely that cheaper generic combinations will compete with Qsymia sales.
Sometimes pills can be split easily and liquid formulations are easily titrated, I doubt that will be the case with replacing Qsymia with generic topiramate and phentermine.
Green Mountain, Is A Merger Brewing? [View article]
Williasp, Thank you, your point was supposed to be part of the rational for "makes a lot of sense". Also, SBUX will keep selling for GMCR's new machine, which also dampens the loss of patent protection some I suppose.
Kiar97, on "exchanged comments", I suppose you could consider your words comments, but I suspect another noun would be more precise. Your previous words were "Second: In what world do you think HGSI will attract a premium in takeover by GSK. Apparently, you have no clue as what is going on in the pharmaceuticals world. HGSI is trading at 13."
The HGSI buyout was raised to $14.25 per share from about $13.50, about a 5% gain in around a week with what I thought was little downside risk.
Fenofibrate is likely the market leader for treating high triglycerides, ii.e., the same market as AMR101. Data from the ACCORD trial did not demonstrate that reducing triglycerides with a drug decreased cardiovascular risk. Also, Lovaza is approved only for treating high triglycerides, not for reducing cardiovascular risk. For AMR101, it impacts whether the potential market is 4 million or 40 million plus patients.
Can't comment on the LEARN program (Qnexa), although it seems to be used by centers, and the diet and exercise intervention on the Blossom (Lorcaserin) trial seems very good. Wonder whether Lorcaserin (or Qysymia) enhances or reinforces diet and exercise intervention, i.e., what would happen if patients take Lorcaserin (or Qsymia) in the absence of a diet and exercise intervention?.
Patient population would also matter in trying to compare these trials.
Apparently, OB303 had a wider range (on the high side) of subject's BMI range as measured by kg/m2.
lorcaserin - Blossom
Men and women ages 18–65 yr (inclusive) were recruited at 97 academic and private clinical trial sites in the United States. Key inclusion criteria were body mass index (BMI) of 30–45 or 27–29.9 kg/m2 in the presence of hypertension, dyslipidemia, cardiovascular disease, impaired glucose tolerance, or sleep apnea and ability to participate in a moderate-intensity exercise program. Key exclusion criteria included recent cardiovascular events, major surgeries, medical conditions that would preclude participation in a nutritional and physical exercise program, diabetes mellitus, systolic blood pressure 150 mm Hg or higher or diastolic blood pressure 95 mm Hg or higher, triglycerides higher than 499 mg/dl, use of a selective serotonin reuptake inhibitor within 1 yr, previous bariatric surgery, recent use of weight-loss drugs (within 1 month for over-the-counter agents, 3 months for prescription drugs) or very-low-calorie diet, or change in weight of at least 5 kg within 3 months. The trial employed no exclusion criteria based on echocardiographic results.
OB 303 - Qnexa
All subjects were eligible to enroll in the extension study if they completed the CONQUER study on treatment and complied with protocol requirements. Inclusion and exclusion criteria for CONQUER required subjects to have a BMI (in kg/m2) of ≥27 and ≤45 as well as ≥2 weight-related comorbidities, as previously described in detail (17). To continue into the SEQUEL extension study, female subjects of childbearing potential were required to continue contraception in the form of a double-barrier method, stable hormonal contraception plus single barrier, or tubal ligation. Exclusion criteria included having a BMI ≤22 at the completion of the CONQUER study, continuously not taking the study drug for >4 wk at the completion of the CONQUER study, developing a condition during the CONQUER study that would interfere with compliance or attainment of study measures, or participating in another formal weight-loss program.
Red Acre, interesting comment. I suppose you are suggesting greater diet and exercise effect in both arms would diminish the difference in the drug arm. All the trials have a significant placebo effect, I do not conclude the placebo effect in the Loracaserin trials would explain the apparent better efficacy of Qnexa.
Weight Issue is correct that both arms have diet and exercise counseling.
Below - From the trial design publications, the description of that intervention.
Nutritional and physical exercise counseling were provided at baseline; wk 1, 2, and 4; and monthly thereafter. Patients were instructed to reduce daily caloric intake to 600 kcal below individual estimated energy requirements, using World Health Organization equations (19) and a fixed activity factor of 1.3 (1.4 for any subject who reported ≥1 h of aerobic exercise per day), and were encouraged to exercise moderately for 30 min per day. Food diaries were used as motivational tools and to assist with counseling sessions; data related to self-reported food intake and exercise were not formally analyzed.
All subjects continued to receive standardized diet and lifestyle-modification counseling based on the LEARN (Lifestyle, Exercise, Attitudes, Relationships, and Nutrition) program (Brownell K. The LEARN program for weight management. Dallas, TX: The Life Style Company, 2000).
In general, it's usually not wise for a company to comment on analyst reports, share price, price volatility, etc. Several posters have expressed concerns that this situation should be commented on.
I agree that Seeking Alpha posts should be held to a higher standard involving polite intellectual discussion, which does not mean you cannot post a strong opinion.
Agree, not 2014 - as soon as 3Q 2013- I'll submit a correction. Your article was linked and here's the release from Globe Newswire on Seeking Alpha that discusses possible launch dates.
Qsymia Approved On The Heels Of Lorcaserin; Buy, Sell, Or Wait And See? [View article]
Qsymia is controlled release formulation of topiramate, it's not just generic Topamax. The time course of serum levels, especially peak serum levels will be quite different. I won't venture a guess on whether higher peak serum levels would increase the adverse effects of topiramate, but that would be a concern.
Aegerion Vs. Isis: Which One Is The Buy? [View article]
With Share Offering Registration And Trial Enrollment Complete, Time To Buy MannKind [View article]
wCoast, share dilution, yes, but it brings cash in at whatever price they can sell the shares at, so I guess I would expect the lowest share price might be soon after an actual offering, not as much as the percentage dilution however.
I think trying to get in at the lowest price, based on new information, needs to be balanced with the possibility that optimism about approval and potential sales of Afrezza may rise, and share price accordingly.
Merck's Entry Into The Parkinson's Disease Drug Race [View article]
Vivus (VVUS) -6.2% premarket after Jefferies downgrades shares to Underperform, citing generic competition. While investors have been concerned about patents for the weight-loss drug Qsymia, the firm thinks doctors may choose to prescribe generics since branded Qsymia is unlikely to be covered by payors and the two generics will be more affordable for patients. [View news story]
http://seekingalpha.co...
Sometimes pills can be split easily and liquid formulations are easily titrated, I doubt that will be the case with replacing Qsymia with generic topiramate and phentermine.
Green Mountain, Is A Merger Brewing? [View article]
http://cnnmon.ie/Ql8e3N
If AMR101 Is Approved, Sell Amarin [View article]
The HGSI buyout was raised to $14.25 per share from about $13.50, about a 5% gain in around a week with what I thought was little downside risk.
If AMR101 Is Approved, Sell Amarin [View article]
http://seekingalpha.co...
If AMR101 Is Approved, Sell Amarin [View article]
On Efficacy, Vivus Vs. Arena [View article]
Patient population would also matter in trying to compare these trials.
Apparently, OB303 had a wider range (on the high side) of subject's BMI range as measured by kg/m2.
lorcaserin - Blossom
Men and women ages 18–65 yr (inclusive) were recruited at 97 academic and private clinical trial sites in the United States. Key inclusion criteria were body mass index (BMI) of 30–45 or 27–29.9 kg/m2 in the presence of hypertension, dyslipidemia, cardiovascular disease, impaired glucose tolerance, or sleep apnea and ability to participate in a moderate-intensity exercise program. Key exclusion criteria included recent cardiovascular events, major surgeries, medical conditions that would preclude participation in a nutritional and physical exercise program, diabetes mellitus, systolic blood pressure 150 mm Hg or higher or diastolic blood pressure 95 mm Hg or higher, triglycerides higher than 499 mg/dl, use of a selective serotonin reuptake inhibitor within 1 yr, previous bariatric surgery, recent use of weight-loss drugs (within 1 month for over-the-counter agents, 3 months for prescription drugs) or very-low-calorie diet, or change in weight of at least 5 kg within 3 months. The trial employed no exclusion criteria based on echocardiographic results.
OB 303 - Qnexa
All subjects were eligible to enroll in the extension study if they completed the CONQUER study on treatment and complied with protocol requirements. Inclusion and exclusion criteria for CONQUER required subjects to have a BMI (in kg/m2) of ≥27 and ≤45 as well as ≥2 weight-related comorbidities, as previously described in detail (17). To continue into the SEQUEL extension study, female subjects of childbearing potential were required to continue contraception in the form of a double-barrier method, stable hormonal contraception plus single barrier, or tubal ligation. Exclusion criteria included having a BMI ≤22 at the completion of the CONQUER study, continuously not taking the study drug for >4 wk at the completion of the CONQUER study, developing a condition during the CONQUER study that would interfere with compliance or attainment of study measures, or participating in another formal weight-loss program.
On Efficacy, Vivus Vs. Arena [View article]
On Efficacy, Vivus Vs. Arena [View article]
Weight Issue is correct that both arms have diet and exercise counseling.
Below - From the trial design publications, the description of that intervention.
Lorcasrin – BLOSSOM - http://bit.ly/PTLd24
Nutritional and physical exercise counseling were provided at baseline; wk 1, 2, and 4; and monthly thereafter. Patients were instructed to reduce daily caloric intake to 600 kcal below individual estimated energy requirements, using World Health Organization equations (19) and a fixed activity factor of 1.3 (1.4 for any subject who reported ≥1 h of aerobic exercise per day), and were encouraged to exercise moderately for 30 min per day. Food diaries were used as motivational tools and to assist with counseling sessions; data related to self-reported food intake and exercise were not formally analyzed.
Qnexa - OB303 - http://bit.ly/PTLbXU
All subjects continued to receive standardized diet and lifestyle-modification counseling based on the LEARN (Lifestyle, Exercise, Attitudes, Relationships, and Nutrition) program (Brownell K. The LEARN program for weight management. Dallas, TX: The Life Style Company, 2000).
Vivus Vs. Citron, Buy Vivus [View article]
I agree that Seeking Alpha posts should be held to a higher standard involving polite intellectual discussion, which does not mean you cannot post a strong opinion.
Vivus Vs. Citron, Buy Vivus [View article]
http://seekingalpha.co...
Vivus Vs. Citron, Buy Vivus [View article]
http://bit.ly/OMx5Gf
Qsymia Approved On The Heels Of Lorcaserin; Buy, Sell, Or Wait And See? [View article]