The afternoon session at Monday's AdCom will be a passion play. Gone will be the statistical demands of the FDA. The committee will hear first person testimonies from many positively affected by Etip. There will not be a dry eye in the room.
The way I see it, if the docs think Etip is not an outright fraud, they will answer the questions positively. This gets the monkey off their backs and onto the FDA.
This year's ASM was not as upbeat as last year's. But it was not down. Everyone one knew MNKD has one more chance to take the #$%$ down the ice and score.
The most patients SNY got was 2,500 at one time. This is from the entire US. Drop outs killed the program.
The huge amount of inventory sold to SNY will mostly be scrapped. More losses added to the $60 mln already on the books. It turns out this debt is secured by MNKD's Valencia's building.
SNY used its very large sales and marketing staff to cover the diabetic waterfront. Castanga will only initially have 40 reps calling on endos. Type 2 will be put on the back burner. Primary care also.
The big question is will Mike Castanga run into the same problems SNY encountered? My take is that he is far more focused than SNY ever was. He has 1 year's data to work from. But even he said drug relaunches rarely go well. Because he signed onto MNKD, he must believe this does not apply to Afrezza.
MNKD needs 12 months to prove weather they can make a go of Afrezza. To do so requires more cash, probably another $50 mln.
I was at the MNKD Afrezza AdCom meeting two years ago. Compare and contrast from the early pictures:
Diabetes population is 4 orders of magnitude larger than DMD. The number of of people at today's meeting is overwhelmingly disproportional.
The Etep AdCom room is twice the size of Afrezza's.
The public and political bombardment pre-meeting for ETEP is much greater than for Afrezza.
Longs should be prepared for a distressing am session. It will be scientists arguing against each other on the technical metrics of Etep. If your child does not measure up to Common Core tests, you must defend why it does not matter.
The pm is where the battle will join. The same parent with a failed Common Core son will say that her son is just as smart as any other child his age notwithstanding the bogus CC tests. She will get support from many corners.
I remember at the Afrezza meeting, the tide turned early in the pm session. I see the same atmospherics in today's meeting. If the committee goes against the public outcry, then I think their personal safety is at risk.
MNKD only has 250 people and is still a developmental stage company. Its plant in Danbury is way too large for the market at this time. Cash burn rate is $10-12 mln/mo. Do some back of the envelope calculations and one can estimate they need 100k users just to be cash flow neutral. The existing base is 2.5-3k users. Mike Castanga is an energetic guy and will do well. But to get to 100k users, it will take years.
MNKD probably needs $200-300 mln to get to cash flow neutrality over the next 2-3 years. Partnerships will bring in some cash. So will product sales. But there is a funding gap that will rear its ugly head.
The best hope is that Afrezza goes viral in the diabetic community.
Hi Len: It is getting interesting at MNKD. But they need money.
SRPT is a different story. Similar to the surprise at the MNKD Adcom, I expect a surprise tomorrow.
It really depends if desperate shorts got to cover. Some may want to initiate a short at this level.
I think there may be another short squeeze rally up to $9. I will get out at that time.
The recapitalization will result in dilution. Deep sea rigs will be the last CAPEX to turn around. First will be tight oil.
It was only a few weeks ago that WLL was less than $3.00 ps. Now it is at $9.00. Their entire 2016 plan is to hunker down for the rebound. Other frackers are doing the same.
It is time for the big boys like XOM to buy Bakken assets. WLL is a prime target. I am sure XOM tried to steal them for less than $20 ps in hopes that WLL's leverage would make them sweat. But WLL will survive and the turnaround is only months away. They and all frackers will have a mountain of DUCs to increase production so the share price will keep on rising.
How will XOM value WLL today for a buy-out? I don't think they would take less than $30 ps. I think $60 ps is more likely.
"I'll buy a bottle" said the shill to the medicine man. This is the type of fraud the FDA was set up to stop. For the most part, it has done a good job at a very expensive price. P3 studies typically cost tens of millions $$$.
Are the same protocols useful for the modern day? Are costly clinical trials needed to weed out the ineffective from the truly good drug? How can any DMD patient enroll in a placebo controlled study knowing he has 50% of dying early?
The FDA, being the incumbent, refuses to answer the questions directly. But they turn to the AdCom committee to find some answers. It may be that for just this case ET gets a hall pass. Or the FDA will revert to time honored protocols and call for a statistically driven (large n) study for ET.
Hopefully we will find out Monday.
VRX's acquisition had muddled their accounting. There is concern that their non-GAAP numbers are hiding some bad truth much like an Enron. Accounting firms are keenly aware of Enron and have taken extra measures to scrutinize books before they put on their stamp of approval.
The bottom line is if VRX can spin off cash from operations to pay down debt, then there is nothing hidden in the books. This is the bottom line.
Titrating Afrezza should not be a mystery given all the clinical trials performed with the product. It is after all, insulin in a different carrier. Having only 20k try the product in the first year is a problem. With over 1 mln Type 1 DB in the US, you would think first year would be six figures. I think SNY gave up after 6 months and quietly told their reps to hump something else. Like Tuoujeo.
I cannot believe my eyes. Investors who own SRPT are going crazy in the weekly put market for next week. Obviously they want to gain downside protection for their stock. But they are paying through the nose. I just sold the April 29 weekly with a strike price of $8 for a premium of $1.00 ps. That is a 12% premium for a strike price $6.40 out of the money. Incredible.
If the AdCom goes against SRPT, nobody believes the company will go away and die. ET works but not to the fussy standards of the FDA. SRPT would then reload and obtain more data.
I have never seen this in all my days trading options.