seems like you folks can't use facts to refute what I say. Go read the DCCT trial manuscripts and understand why the significantly inferior performance of this insulin is a big deal over time
I wouldn't rule out that a mid tier company starved for product would partner with MNKD but I would bet the real upfront cash will be less than 1/3 of current debt (and that debt keeps growing) - then MNKD would only have part of drug, would still have a ton of money to invest in the launch, and would still have the same problems with the drug risks
it is maybe 8 posts this year - not since 1999. I have been waiting for this approval to happen because I worked for years in the diabetes space. If you understand the long term diabetes trials then it explains why an inferior drug with risks won't overcome a perceived ease of use
there was a pop because of the approval but the approval didn't solve the problems this drug has and the approval documents shows additional problems and risks
there is nothing MNKD can do except show sales but that isn't going to happen
even if there is a partnership I would expect the terms to be surprisingly poor
you still have people that are willing to lend the company money but they are burning through cash and haven't got to the launch and debt is rising. A bad start to sales and MNKD could be done
1. bronchospasm risk
2. is there a long term cancer risk?
3. this is proven to be significantly less efficacious compared to other insulins and that will lead to the development of secondary diabetes sequelae
4. longer term lung risk?
5. failure of previous inhaled insulin
6. many companies that had inhaled insulin programs abandoned them after exubra failed - why go back and try a failed previous product
The motley fool article does a good job at pointing out a few problems that MNKD will run into
1. it does not work as well as novolog for controlling HbA1c - according to the DCCT trial the increased HbA1c from using Afrezza would be expected to lead to a much higher level of diabetes associated sequelae over time
"Unfortunately it also points out that the patients taking Novolog saw their HbA1c -- a measure of long-term blood glucose levels -- drop more than patients taking Afrezza: 0.4 points versus 0.21 points. More patients in the Novolog group also reached the goal levels of HbA1c than in the Afrezza group: 27.1% versus 13.8%."
2. the lung testing before you start and every 6 months is going to be a hurdle to overcome. If there is any drop at all over time in lung function then MNKD will be dead almost overnight
3. MNKD needs to do a clinical trial to look for lung cancer risk. That killed exubra. Another item that will keep people form even considering inhaled insulin and also one that could kill this product overnight if any risk is found. It was found in exubra
go read the DCCT trial results if you want to invest in anything diabetes related
I am sure everyone here knows everything about why exubra failed and think that this drug won't. This company has a serious cash burn problem that will just get worse as it tries to move to market. When it doesn't sell in the first 6-12 months the slide to under 1$ will be well underway.
The bronchospasm adverse events will scare some people away but the big problem is that it is worse than current insulins are reducing HbA1c - and it is worse in a statistically significant manner. So it is more dangerous and doesn't work as well as current short acting insulin. Anyone who has read the diabetes literature knows that even a slightly worse glycemic control means a much worse long term outcome (see the DCCT trial)
From the FDA press release "Afrezza provided less HbA1c reduction than insulin aspart, and the difference was statistically significant."
I would also not want to worry about long term changes in the lung from inhaled insulin. Time will tell but I would guess it won't take long for this stock to tumble - maybe 6 months or less.
nobody is asking why renesas sold for a mundane multiple - probably because they lost the apple business that they had previously
Funny that syna trades at 3.9x revenues when it buys similars companies (at a premium) for 0.8 times revenues. So would a non-takeover premium be 0.5-0.6 times revenues? Apply that to syna and the stock price would be $12-13.
Anything seems possible in this market but what happens when people realize that renesas lost its apple business. The CEO wouldn't confirm any contract with apple this evening
maybe there is more to the story than that but a quick review of the side effects of other approved TKI agents show higher diarrhea rates
it is possible that the drug is now worth much much less and the market hasn't priced that in yet
if there is a major safety issue then this drug is dead. At this point it seems they need to go back and test lower doses and redo the studies
just look at the chart and realize that 300X revenues doesn't last long
you have to be careful because GWPH reports total revenues but that is not products sales. 300x yearly sativex sales sounds like a bubble
It likes nobody saw what happened to PLUG today and nobody saw what happened the last time the biotech bubble collapsed or the tech bubble collapsed in 1999.
I hope that #$%$ is approved all throughout the US for those that need it but for GWPH it would bring crushing low cost competition.
Sativex is still a slow growth drug with plenty of cannabinoid receptor agonists in development as well as other approved CBD products - that is why GWPH went public less than a year ago at $8.9 and was less than 11 in september
not to mention plenty of other competitors in the space.
This is just like 1999 where 40X revenues when you are growing at 10% per year is OK because of the super bright future.
There is a reason why GWPH went public less than a year ago at 8+ dollars a share.
One sanjay gupta tv show is over and the blood comes off the biotech bubble I would expect a rather long fall for gwph. What is even funnier is that #$%$ should actually out-compete sativex - it shouldn't be a reason for gw pharma to rise if #$%$ is much cheaper and easier to get
he has been promoting several years of 50% growth for years - and this year sales are down. Seems criminal to continuously promote your company with obvious lies
I guess people are hoping the CEO will save them with some more overpromise hype
they have sold 82 million shares for 68 million dollars in the last year just to stay alive
This is just a trading event. PLUG is selling the same old technology that has seen shrinking sales over the last 15 years.