MannKind's Afrezza Likely To Easily Gain Approval [View article]
Adam F. is a political science major, which is somewhat different than bio-medical science, his opinions hence have more political science flavor and should be taken as such
MannKind's Afrezza Likely To Easily Gain Approval [View article]
Sub $1 in Aug ? Equity Options Guru, no offense intended, but it might be better if you confined your opinions to yahoo message boards, though there you would be on ignore list of most. You article an comments are one of the most unreasoned and biased I have seen in years on SA. This stock has a far better chance of going up like Kerx than sub $1
2 Biotechs With A Strong Risk Of Failure [View article]
Equity Options Guru,
The kind of article you have written tears apart every thing SA tries to convey to fundamental investors which is truth, integrity and well researched journalism. Your article is shoddy journalism at the best, it does not help provide facts to fundamental investor but distorts them, possibly self serving. As Kevinmik pointed out so well, in fact you provide the worst possible service to the average investor. If you have any integrity behind what you have written, let's see a reasoned response to Kevinmix
2 Biotechs With A Strong Risk Of Failure [View article]
Excellent break up of the data Kevin. Unfortunately this article is so poorly researched or simply targeted to generate sensationalism/ negative sentiment for whatever reason by cherry picking the data. This is about as poorly "researched article" or biased journalism I have seen anywhere. Looking at the data, and the way the trials are designed, as a medical professional I think the chances of success for MNKD are at least 95% in the coming months
MannKind's Afrezza Likely To Fail AFFINITY 1 Phase III Trial [View article]
The data the author is referring to is with the old medtone inhaler, the company is not looking for an approval for it. The Dreamboat is going for FDA approval, it is the new generation inhaler, supposed to far superior and better data is expected of it. In my opinion the way the trial is designed, it will be highly unlikely that it will fail non-inferiority and may well turn out to be overall better. Mark my words.
Many times, both investors and traders do not understand how offerings work, and automatically assume the stock price will go down. One such vehicle is an at-the-market (ATM) offering. An ATM is an offering of newly issued shares into the existing trading market. It enables the issuer, through the services of a broker-dealer acting as an agent, to sell stock into the market over a period of time determined by the issuer at a minimum price that is also determined by the issuer. If managed effectively by the agent, the shares are sold at the prevailing market price. There is no offering discount. There are no warrants. Unlike a line of credit, the shares are not sold to previously identified parties at a discount to the volume-weighted average price (VWAP), but they are sold at the market price. This results in a lower cost of capital compared to more traditional financing approaches. In addition, an ATM provides the company with more control on the timing of capital-raising. It is complementary with other financing activities, so one could supplement a more traditional financing with an ATM. Therefore, ATMs are tools for companies that are seeking to build solid, long-term financing strategies incorporating several financing vehicles that provide flexibility and reduce the overall cost of capital.In just about every case of a direct ATM offering, the stock normally rises quite a bit. The kind of financing that can be negative on a stock is when a company engages in a private placement, with tons of warrants issued to "private investors." On January 18th, Trius engaged in a public offering at the market (ATM) price of $4.75 a share. Often times, when small cap biotechs "dilute" the share price heads down. This was not the case with Trius, as the stock rallied on the offering to near $5 in a couple of trading sessions and now is close to $7. In May of 2012, Arena Pharma (ARNA) did an ATM at $5.50, soon after the stock zoomed to $12
"My conclusion is that Afrezza's approval prospects are 50/50 " - And why would that be ? Afrezza met FDA's goal posts for approval in 2011, but MNKD change of inhalers at the last minute resulted in CRL. FDA did not have any issue with the efficacy, they just needed trials to be done with the new inhaler. The new inhaler is an advanced version of the old one, why would you have reason to believe that it has only 50% chance of making it through this time ? Besides FDA has already approved exubera in the past(it was pulled by Pfizer not FDA) so why will FDA not be inclined to approve another inhaled insulin this time around ?
I don't know David from Adam but it appears to me that he just decided to short MNKD based on the secondary offering and then built a short thesis around it.
MNKD is 2 months away from trial completion, results a few months after. As the dates get closer, the price should escalate to $4 or even more. To expect the stock to go lower much lower than what is now, or expect the stock to dip below $3 and short it is risky I think.
5 Reasons MannKind Could Be The Best Performing Stock Of 2013 [View article]
It always helps the stock when management does secondaries, but Alfred Mann seems to have more than enough to donate $70 million to his charity 2 weeks ago!
Dwindling Cash And Risky Bets - New York Mortgage Trust May Roll Craps [View article]
The company has 3 employees with a rash of secondaries and earnings miss. I rather put my money elsewhere, it looks more and more likea poni scheme to me
Upcoming NDA, Potential Partner Add Further Investment Value For Pozen [View article]
Scott,
Most patients do fine on aspirin 81 g with food without the need for prilosec (or similar drugs) to prevent peptic ulceration. It is only a minority of patients who are at high risk for pepic ulceration who are put concomitantly on medications like prilosec or pepcid to reduce the risk of peptic ulceration. Most insurance companies even now have a big problem paying for PPI's (prilosec, nexium prevacid, protonix, aciphex etc)even when patients has severe reflux or peptic ulcer bleed, they just want patients to get OTC prilosec or prevacid instead, so that they don't have to pay a cent. Similarly most insurances companies do not even cover aspirin and patients get that OTC. So I really cannot imagine a situation in which insurances would like to pay for Pozen's PA32540 at $1.16 a pill, in all probability they will just direct their patients to take prilosec 20 mg and aspirin OTC and not pay a cent, at worst pay for a 20mg prilosec OTC which would be 1/2 the cost.
Upcoming NDA, Potential Partner Add Further Investment Value For Pozen [View article]
You already mentioned it "One can also buy 42 20 mg tablets of OTC Prilosec (omeprazole) for $23.95, or around 57 cents per pill. To re-create Pozen's PA32540, a patient would spend approximately $1.16 per day (taking two Prilosec pills plus an aspirin).
81 mg aspirin costs about 1cent/day. So 81 mg aspirin+prilosec 20 mg OTC would be about 58 cents a significant cost advantage compared to Pozen's PA32540 $1.16/day and quite likely "getting at least equal benefit". As I explained in my response above there is no data suggesting that 40 mg of prilosec is better than 20 mg in this regard, in fact the lower dose of 81 mg used with 20 mg prilosec probably makes it even more unlikely (325 mg aspirin has been shown to cause higher incidence of peptic ulceration)
Upcoming NDA, Potential Partner Add Further Investment Value For Pozen [View article]
The question is if PA32540 is significantly superior to 20 mg omeprazole+ 81 mg aspirin OTC, there is none. In fact there is some data that there is not much difference between 20 mg and 40mg mg ompeprazole for ulcers (1)
There is considerable data with omeprazole 20 mg in reducing peptic ulceration with aspirin and is currently the standard of care to reduce risk of peptic ulceration in high risk patients, without comparative study with PA32540 there is no way of determining if the extra 20 mg of omeprazole in the product is necessary or causes a statistical benefit . Besides, latest data has shown that benefit of aspirin 81 mg is equal to 325 mg( but aspirin 325 mg has greater bleeding - this includes GI bleeds, cerebral, epistaxis, other extra gastrointestinal sites). There is also data showing that more than 81 mg aspirin daily can be detrimental in management of CHF in patients. So truly speaking there is no role for 325 mg aspirin oer 81 mg anymore in primary or secondary prevention of vascular disease. Hence, there is a possibility that PA32540 might statistically increase non-peptic ulcer bleeds on account of higher aspirin content compared to 81 mg aspirin + omperazole 20 mg with little of no extra benefit in peptic ulceration/bleeds.
Hence for a clinician there is really not much use for PA32540 over aspirin 81 mg + OTC omeprazole 20mg. As a physician I would be hard pressed to prescribe the combo at all. It is an another me too drug we can do without and not a stock I would put my money in. I can say with considerable certainly that the sales will be disappointing, but certainly the stock could be played around the catalysts.
MannKind's Afrezza Likely To Easily Gain Approval [View article]
MannKind's Afrezza Likely To Easily Gain Approval [View article]
2 Biotechs With A Strong Risk Of Failure [View article]
The kind of article you have written tears apart every thing SA tries to convey to fundamental investors which is truth, integrity and well researched journalism. Your article is shoddy journalism at the best, it does not help provide facts to fundamental investor but distorts them, possibly self serving. As Kevinmik pointed out so well, in fact you provide the worst possible service to the average investor. If you have any integrity behind what you have written, let's see a reasoned response to Kevinmix
2 Biotechs With A Strong Risk Of Failure [View article]
MannKind's Afrezza Likely To Fail AFFINITY 1 Phase III Trial [View article]
Biotech: Hedging While Speculating [View article]
MannKind: A Pure Speculative Bet [View article]
Facts about ATM financing
Many times, both investors and traders do not understand how offerings work, and automatically assume the stock price will go down. One such vehicle is an at-the-market (ATM) offering. An ATM is an offering of newly issued shares into the existing trading market. It enables the issuer, through the services of a broker-dealer acting as an agent, to sell stock into the market over a period of time determined by the issuer at a minimum price that is also determined by the issuer. If managed effectively by the agent, the shares are sold at the prevailing market price. There is no offering discount. There are no warrants. Unlike a line of credit, the shares are not sold to previously identified parties at a discount to the volume-weighted average price (VWAP), but they are sold at the market price. This results in a lower cost of capital compared to more traditional financing approaches. In addition, an ATM provides the company with more control on the timing of capital-raising. It is complementary with other financing activities, so one could supplement a more traditional financing with an ATM. Therefore, ATMs are tools for companies that are seeking to build solid, long-term financing strategies incorporating several financing vehicles that provide flexibility and reduce the overall cost of capital.In just about every case of a direct ATM offering, the stock normally rises quite a bit. The kind of financing that can be negative on a stock is when a company engages in a private placement, with tons of warrants issued to "private investors." On January 18th, Trius engaged in a public offering at the market (ATM) price of $4.75 a share. Often times, when small cap biotechs "dilute" the share price heads down. This was not the case with Trius, as the stock rallied on the offering to near $5 in a couple of trading sessions and now is close to $7. In May of 2012, Arena Pharma (ARNA) did an ATM at $5.50, soon after the stock zoomed to $12
MannKind: A Pure Speculative Bet [View article]
I don't know David from Adam but it appears to me that he just decided to short MNKD based on the secondary offering and then built a short thesis around it.
MannKind: A Pure Speculative Bet [View article]
5 Reasons MannKind Could Be The Best Performing Stock Of 2013 [View article]
Dwindling Cash And Risky Bets - New York Mortgage Trust May Roll Craps [View article]
Chesapeake Energy: Ready To Double [View article]
Upcoming NDA, Potential Partner Add Further Investment Value For Pozen [View article]
Most patients do fine on aspirin 81 g with food without the need for prilosec (or similar drugs) to prevent peptic ulceration. It is only a minority of patients who are at high risk for pepic ulceration who are put concomitantly on medications like prilosec or pepcid to reduce the risk of peptic ulceration. Most insurance companies even now have a big problem paying for PPI's (prilosec, nexium prevacid, protonix, aciphex etc)even when patients has severe reflux or peptic ulcer bleed, they just want patients to get OTC prilosec or prevacid instead, so that they don't have to pay a cent. Similarly most insurances companies do not even cover aspirin and patients get that OTC. So I really cannot imagine a situation in which insurances would like to pay for Pozen's PA32540 at $1.16 a pill, in all probability they will just direct their patients to take prilosec 20 mg and aspirin OTC and not pay a cent, at worst pay for a 20mg prilosec OTC which would be 1/2 the cost.
Upcoming NDA, Potential Partner Add Further Investment Value For Pozen [View article]
81 mg aspirin costs about 1cent/day. So 81 mg aspirin+prilosec 20 mg OTC would be about 58 cents a significant cost advantage compared to Pozen's PA32540 $1.16/day and quite likely "getting at least equal benefit". As I explained in my response above there is no data suggesting that 40 mg of prilosec is better than 20 mg in this regard, in fact the lower dose of 81 mg used with 20 mg prilosec probably makes it even more unlikely (325 mg aspirin has been shown to cause higher incidence of peptic ulceration)
Upcoming NDA, Potential Partner Add Further Investment Value For Pozen [View article]
There is considerable data with omeprazole 20 mg in reducing peptic ulceration with aspirin and is currently the standard of care to reduce risk of peptic ulceration in high risk patients, without comparative study with PA32540 there is no way of determining if the extra 20 mg of omeprazole in the product is necessary or causes a statistical benefit . Besides, latest data has shown that benefit of aspirin 81 mg is equal to 325 mg( but aspirin 325 mg has greater bleeding - this includes GI bleeds, cerebral, epistaxis, other extra gastrointestinal sites). There is also data showing that more than 81 mg aspirin daily can be detrimental in management of CHF in patients. So truly speaking there is no role for 325 mg aspirin oer 81 mg anymore in primary or secondary prevention of vascular disease. Hence, there is a possibility that PA32540 might statistically increase non-peptic ulcer bleeds on account of higher aspirin content compared to 81 mg aspirin + omperazole 20 mg with little of no extra benefit in peptic ulceration/bleeds.
Hence for a clinician there is really not much use for PA32540 over aspirin 81 mg + OTC omeprazole 20mg. As a physician I would be hard pressed to prescribe the combo at all. It is an another me too drug we can do without and not a stock I would put my money in. I can say with considerable certainly that the sales will be disappointing, but certainly the stock could be played around the catalysts.
(1) http://bit.ly/WNX74U