None of the Afrezza data have been presented at a medical meeting or published. All we've got are MannKind press releases and a weird FAQ filed with the SEC, which means the mediocre study results we're seeing are the best Afrezza is ever going to look. When the FDA starts ripping the Afrezza data apart, who knows what happens? I won't be surprised if the agency finds enough bad stuff to conclude one or both of the studies failed and that the product is not approvable.
There's certainly precedent for an Afrezza rejection. Two, actually. And in both instances, MannKind was not open and honest with investors. To me, it's risky to have any confidence in MannKind management or the Afrezza data.
Could I be wrong about predicting an FDA rejection? Absolutely. The FDA acquiesced on Vanda Pharma (VNDA) so it's entirely possible that Afrezza gets a similar softball review and is approved.
Last August, I gave Afrezza 50-50 odds for approval. So, let's say I'm at 60-40 for rejection today.The more confident bear thesis on MannKind is still Afrezza being approved but ending up a total commercial flop.
Prepare yourself for a batshit-crazy email on Inovio Pharma (INO - Get Report). Daren R. objects to last week's Mailbag:
Dear Adam I must say your recent article about the company Inovio pharm is a little bit condrecting didn't you just say a few weeks ago the company stock was up over 400 % in the year of 2013, you honestly sound like a person who is shorting the stock and trying to put the fear of god into people so they will sell their shares. I have to ask you please prove to me how you feel this company which was founded in 2009 is a 34 year old company. by all means please prove to me how it was created in 1979 and has had numerous failed attempts of their vaccines and immunetherapy, Wow I used to like Jim Cramer but if he has some one like you working for him I think I have to stop watching him and honestly I really hope its just a matter of time when the SEC knocks on your door. Please remember when you were growing up did your mother ever tell you if you don't have anything nice to say about someone or a company then really you need to show some respect and keep quiet , for your sake I really hope that some one in your family that gets sick from cancer or aids and you come calling for help with Inovio and they find out its you and deny you healthcare treatment because you are skeptical wow what does Jim Cramer see in you any way. you know I bet you not once have you ever had the chance to have an interview with the CEO Dr Kim of Inovio why don't you do your self a favor and speak with the man before you start spewing out lies only so your buddys can short the stock gee can you do me a favor will you send me an email so I know to hold off and buy when I can get them cheaper, Well for what I have been reading about you it looks like you have been wrong a few times about your picks on stocks. well like the guys all say on the yahoo message board like clock work as so a stock climbs you have to bad mouth it. do your self a favor and have an interview with the board of directors of Inovio have of them are from a little pharmecutical company called MERCK so please do your home work because when this stock dwarfs has a great year and dwarfing 2013 in 2014 be careful you may have to eat a big plate of crow or you may wake up with egg on your face some morning. gees JIM CRAMER HAS TO PICK A BETTER person then you but please buy all means please in your next article please explain to us how this company is 34 years old I really would like to know and if you are and you can prove me wrong I will gladly be the gentleman I am and apologize to you . thanks Topgun just because I am the best at what I do !What to say? It's easy to mock Daren for his incoherence, his rambling prose and almost total lack of punctuation. Done. Gerald H. is also upset with my Inovio skepticism.
Your recent comments concerning Inovio are invalid. Thirty years ago, Inovio under a different name was working on solid tumors using electroporation to deliver bleomycin to the tumor. At that time and up until 2009 when Dr. Kim took over, insiders including the President owned very little if any common stock. Also, up until Dr. Kim's arrival, no work was done on vaccines. Your analysis of Inovio should start when Dr. Kim took over. All events and circumstances before Kim are not relevant to the analysis of Inovio. The Roche deal and Mr. Collins insider common stock purchase are very positive signs that support Dr. Kim's vision.I fundamentally disagree with you, Gerald. I don't buy the argument that there's a legitimate pre- and post-Kim Inovio. Inovio was focused on electroporation before Kim arrived and is still doing so today. The technique, more than 30 years old, involves using electricity to make cell walls more porous to enhance the delivery of drugs. Yet, Inovio has never demonstrated the benefit of electroporation. Gerald mentions the work done by Inovio with the chemotherapy drug bleomycin. What he omits is Inovio, in 2007, was forced to halt two phase III studies of bleomycin delivered via electroporation in head and neck cancer patients. Independent safety monitors found patients were dying at a faster rate in the electroporation/bleomycin arm compared to patients treated with surgery. Nothing in Inovio's pipeline has panned out. There's the HIV drug pictovir, which was shut down in 2008, and more recently, the hepatitis C drug ChronVac-C, which failed a phase II study last April. Gerald says Inovio is all about DNA vaccines today, but ChronVac-C was a DNA vaccine. Failed. Then there are the Inovio pipeline products which seem to on the shelf or forgotten. I'm referring to the flu and pandemic flu vaccines VGX-3400 and VGX-3510 which haven't advanced since 2011. VG-1027 was hailed as a therapy for rheumatoid arthritis and diabetes but work on it has been suspended since 2011. PennVax for HIV seems to be going nowhere and a leukemia vaccine study is suspended. Remind me again how the arrival of Kim as CEO was a positive sign? DNA vaccines and dendritic vaccines share many similarities in the way they're designed to prime a patient's immune system to identify and attack diseased cells. The latter have not lived up to their promise, and I remain highly skeptical that DNA vaccines will prove to be any more effective. One more observation about Inovio for those who point to the Roche (ROG) partnership as validation of DNA vaccines and electroporation: I will remind you that Inovio used to have significant drug development partnerships with Wyeth and Merck (MRK). The former was terminated in 2009; the latter is technically still in place but essentially dead. Also in last Friday's Mailbag, I mentioned a preference for Exelixis (EXEL - Get Report) over Ariad Pharmaceuticals (ARIA - Get Report) in 2014. Dan G. says I made a poor choice:
Good morning baldie. Exelixis vs. Aria. Due to the fact that you are clueless, I am moving my money from Exelixis to Aria. I have no doubt Aria will do better short and long term.Not so far, Dan.
EXEL data by YCharts I'll give this week's last word to Sam. H.
"You are a jerk..."Thanks, Sam. Love you, too. -- Reported by Adam Feuerstein in Boston. Follow Adam Feuerstein on Twitter.