For mgmt. to "strongly" hint an Adcom is not on the horizon would put them at risk of lawsuits, were that unlikely event to occur. I think mgmt. is being smart and not opening themselves up to predatory class action lawsuits. Surely they learned that lesson already... and notice mgmt. seemed to have put Al in the penalty box for a while after he utter the "stupendous" remark on a cc. I think they're just being cautious.
That aside, if there is an Adcom, I'll try to load up on calls expiring post Adcom. Should provide a great trading opportunity with very low risk.
Listen to the last CC. An analyst asked the question you want answered... why did they choose an endpoint that set the bar for success so high. (paraphrasing.. because we knew we could tank the price and friends and family could load up... just kidding but U never know)... anyway mgmt. did answer that question... you'll have to listen to get the answer.
MNKDW is another alternative with expiration at 2016. You can exercise and flip at any time. There's no penalty for early exercise.
Computers working orders, breaking them up into 100 share lots... very common... I used to work for a brokerage firm in market data... would see reams of 100 share orders entering the market then almost immediately being canceled as the algos try to sniff out the market.
Also, I would assume there would be no more prescriptions written for the compounded formulation after VEN 307 is approved. I was a Rogaine user that got the stuff compounded about 18 months before it was approved. After approval, dermatologists all switched to brand name Rogaine. Unfortunately, mgmt. on one of the calls said data isn't collected for compounded drugs, so no clear guidance on the $$$ that would automatically move to VEN 307.
Well... mgmt. says they are working toward that, but they are not there yet. This test rules out patients that don't have appendicitis (around 43% of them). Unfortunately the rest may still need to proceed to CAT scans and/or an MRI to get a conclusive diagnosis of appendicitis..
Would it be anywhere near what Heceptin achieved in 2011? ($5.6B)
Pharma’s Biggest Blockbusters
Brand name Primary indication(s) Peak year
(to date) Peak year sales ($m) Product type
Lipitor Dyslipidemia 2006 13696 Small molecule
Plavix Atherosclerosis 2011 9318 Small molecule
Humira Autoimmune diseases 2012 9265 Biologic
Seretide Asthma/COPD 2011 8148 Small molecule
Enbrel Autoimmune diseases 2011 7830 Biologic
Abilify Schizophrenia 2011 7363 Small molecule
Crestor Dyslipidemia 2011 7021 Small molecule
Rituxan Autoimmune diseases 2011 6798 Biologic
Remicade Autoimmune diseases 2011 6782 Biologic
Losec Dyslipidemia 2000 6260 Small molecule
Avastin Colon, lung, renal cancer 2010 6216 Biologic
Seroquel Schizophrenia 2011 6177 Small molecule
Diovan Hypertension 2010 6053 Small molecule
Herceptin HER-2 + breast cancer 2011 5947 Biologic
Singulair Asthma 2011 5479 Small molecule
Lantus Diabetes 2011 5452 Biologic
Zocor Dyslipidemia 2002 5445 Small molecule
Nexium Gastroesophageal reflux 2007 5216 Small molecule
Zyprexa Schizophrenia 2010 5026 Small
It's going away when the options expire in Jan. and note the JDRF study should release results shortly after the Jan options expire. Seems like good timing to close out the options position and get set up for a run-up to approval.
If you believe the options to be a predictor, looks like liftoff after Jan 14. The big play on call options has been Jan 14 at a $5 strike for a long time. For now, it looks like May 14 calls are predicting a post approval price around $10. The bid is pretty juicy at around $1.
Didn't mgmt. state the cream is already sold by compounding pharmacies? I understood it's already widely prescribed by doctors, but it has to be compounded. If my understanding is correct, the only thing holding back approval would perhaps be manufacturing and quality control issues.... right?
Considering all the bashing of MNKD (including that Adam F stated MNKD should have a mkt cap comparable to BIOD (50M)), I'll take any news that in any way justifies its price. As far as approval, I think it's a good bet, especially given the last time around an FDA insider ended up in jail for trading MNKD after he was informed it was about to be approved... only to have the FDA change their mind a week before their decision after solicitation from a major hedge fund raising legitimate questions of protocol violation (switching inhalers in the trial). For approval this time, MNKD just needs to prove safety and equivalence between their new inhaler and the previous one. Recent studies did that. The previous CRL had no efficacy or safety concerns to be addressed.
I'm hoping to eventually see $5 here. Seems a pretty safe bet.
I think all options are on the table.
Look at SNTS. Glumetza has been around for a few years. It doesn't have a lot more room to grow revenues, yet a company paid more than10 times 2015 revenues... huh? That's crazy to me.
1. MNKD mgmt. is obviously not lying when they have stated they have been AGRESSIVELY pursued by regional players.
2. Don't underestimate the value of MNKD, given it's projected market potential exceeds Glumetza.
3. Looks like price doubles easily from here within a year regardless of a deal with Big Pharma.
Wow.. surprised nobody commented on this one. SNTS was bought for its extended release metformin, with projected 2015 sales of about $220M, for $2.6B !!! They have one other drug generating $100M but Bloomberg states acquisition was for Glumetza.
Also, note it was a second tier pharmaceutical company (Salix - $5B mkt cap) that bought them.
What does that say about the potential price for MNKD?
Congrats. I was also a TSRX investor.
I'm a big investor in MNKD. Given that SNTS was bought for Glumetza for $2.6B is pretty phenomenal. That gives me even more confidence in the potential of MNKD to reach at least a $2B mkt cap.
As far as I know patients that failed gemcitabine are at the end of the line. There is no standard course of treatment beyond that based on various articles I've read. Patients that have had surgery survive longer than those that haven't; obese patients fare worse than others; and I'm sure there are a lot of other factors that could affect survival.
AEZS's perifosine fiasco is another example of where the control group surpassed survival expectations, pushing out the study's endpoint.
Cancer drugs seem to be the highest risk/reward ratio. If the study replicates the phase II results, I would expect to see the price more than triple. However, the phase II study sample size was too small to yield much in terms of statistical significance (but at least it was larger than the AEZS phase two trial).
After reading the pdf, I think this is the most significant figure to remember since this is what ultimately will drive approval:
PEP02 achieved the primary endpoint of 3-month survival rate of 75% in metastatic pancreatic cancer patients who failed prior gemcitabine therapy.