1. The only insider dumping shares (in any quantity) was Anastasios E. Gianakakos and he's been doing it regularly for years. He's been exercising options and selling them for years since he joined the company- just look it up if you don't believe me. Plus he's only exercised a small portion- big deal- this happens all the time.
2. The FDA did not require a SECOND Phase III study. This is big- there is a reason they didn't need it. Think about it.
3. The biggest (and smallest) headache specialists in the country are all predicting (not to the markets but to their patients) approval and are behind this drug: Drs: Goadsby, Silberstein, Saper, etc. Check them out. Plus they were are using Botox for migraine for AT LEAST 10 or more years (it was just approved in Oct 2010.
4. 93% of the stock is institutionally held. This hasn't been peddled to the little guy. Allergan is a big time player. While this doesn't guarantee approval MAPP is not your typical biotech.
5. The most important- DHE really works. It's been approved for over 60 years. According the the World Health Organization:
Among adults of all ages, migraine is one of the top 20 causes of disability expressed as years of healthy life lost to disability (The World Health Report 2001, WHO)
Severe migraine attacks are classified by the World Health Organisation as among the most disabling illnesses, comparable to dementia, quadriplegia and active psychosis (Shapiro & Goadsby, Cephalalgia, September 2007)
Migraine is the least publicly funded of all neurological illnesses relative to its economic impact (Shapiro & Goadsby, Cephalalgia, September 2007)
The FDA knows that doctors are overwhelmed with patients who have "headache disorders" as new headache disorders are being classified all the time and this is a serious public health problem. See here, NIH, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2780664/
Patients need all the help they can get and DHE (yes I am a user) makes my life possible and the Neurology division of the FDA knows this. It is a miracle drug and to have it in an improved inhaled version will make our lives so much easier- they know this and they will decide in favor of the patient and that means approval.
My own doctors (headache specialist Neurologists) have assured me over and over that Levadex will be approved.
I think it should at least offer faster relief than subcutaneous injections or intramuscularly or a nasal spray that works by being absorbed through nasal . Intravenous is rapid onset also but you would have to go to a medical center for IM or IV i beleve. Regulation of dosage in inhaled form would be key.
If I may add, the two noteworthy inhalable drug therapies (Pfizer's Exubera and Mannkind's Afrezza) mentioned here ad-nauseam were failures for a number of reasons.
Exubera - While approved by the FDA, Pfizer withdrew the product from the market. Problems with a) difficulty in the delivery and the conversion of accurately measured doses b) possible lung function degradation, while temporary, due to the complex large protein of insulin, c) bong-size pipe (IE embarrassingly cumbersome delivery method), and d) 2x cost of injectable therapy.
Afrezza - The first CRL issued requested additional data on the clinical utility of Afrezza and more specifically the comparison between MNKD's Medtone safety and efficacy vs. the Afrezza's redesigned second-generation Dreamboat being submitted in the NDA. So MNKD attempted to simply take in vitro performance data and clinical pharmacology data to bridge MannKind's next-generation inhaler to late-stage trials conducted using its current-generation MedTone inhaler, and subsequently the FDA said no in it's second CRL issued - where it asks the company to conduct two clinical trials to run a head-to-head comparison of the Medtone inhaler and the next-generation Dreamboat inhaler that will be marketed with Afrezza.
So while the Exubera and Afrezza had some serious issues, they are all NON-ISSUES with Levadex. In addition, while I will concede that the FDA has been spotty with RDD approvals, Levadex has shown a) undeniably superior efficacy vs. injectable DHE and b) safety concerns (both in the NDA submitted drug formulation and delivery device) that are statistically nil.
I could have a serious argument with you about Afrezza having "serious issues". In fact, Afrezza is a solution for them. Know the facts..somewhere along the way the FDA changed it's mind about allowing the bench data from the new inhaler as a substitute for the original Medtone inhaler where the trials were done on. They now want comparative between old and new inhalers...it is BS. The new inhaler is far superior using less drug to achieve the same result. There were no issues with the drug itself. Once the testing is complete on the new inhaler it will be approved. Afrezza will eventually be one of the biggest drugs of all time. Long VVUS, MAP, MAKO as well as very long MNKD.
Julia, you are a great poster.
Will the FDA panel making the decision be all neurologists or majority neurologists or just some neurologists?
If not all neurologists, what other types of specialists will make up the rest of the panel?
I think the Neurology Division of the FDA is mostly if not all Neurologists all though I do not work there so I don't know for certain. I doctors that I know of in that division are Neuros. :-)
your comments are logical. what about the potential effects on lung functioning. besides the first inhaled insulin exubera, levadex will be the first orally inhaled non-respiratory drug to be approved. though one might say that there is an existing nasal dhe formulation called migranal, I think levadex is quite different delivery system. do you think FDA going to take a more cautious approach and issued a CRL and asked for more tests on effects on lungs?
No significant changes in lung function with patients that were smokers and asthmatics. The point of further studying this would be what? Safety has been established. Inhalational agents are used daily on patients as anesthetics, they work directly on the brain. This will NOT be the first drug used as an inhaled agent other than insulin. Inhalation anesthesia has been around for over 100 years
The NDA submission also includes data from a pharmacokinetics (PK) trial evaluating the PK and safety of LEVADEX in smokers and non-smokers, a pharmacodynamics (PD) trial evaluating the acute effects of LEVADEX on pulmonary artery pressure, a thorough QT trial comparing the acute effects of a supra-therapeutic dose of LEVADEX on the cardiac QT interval as measured by electrocardiogram and a safety trial in adult asthmatics.
I understand your concerns however, MAPP did PK studies (at Duke University and others)on lung function in smokers and asthmatics, specifically:
Systemic exposure to LEVADEX was not higher in smokers, potentially due to reduced pulmonary absorption, in the PK study comparing smokers vs. non-smokers.
There was no difference in pulmonary arterial systolic pressure between the LEVADEX and the placebo group over two hours in the PD study.
Results of the QT trial showed that a supra-therapeutic dose of LEVADEX does not increase QTc intervals.
PK concentrations for LEVADEX in asthmatics were similar to those in healthy subjects.
As you pointed out this wouldn't be the first inhaled drug for an indication that is non-pulmonary related, but the second, and that is still perhaps a hurdle for the FDA but given all the available evidence I still think that the drug will be approved unless they give a soft CRL over manufacturing issues which will be quickly resolved. However, if they had some other issues why not have an AdComm?
Every Neuro insists this will be approved and Neurologists are the ones who will be making the decision at the FDA. In fact, I saw my Neuro yesterday who assured me (again from a patient/doctor POV) that this will be approved and be available very soon. He has been telling me this for over a year. He is a headache specialist. All the headache heavy hitters are saying this to their patients. I just don't know why they would tell their patients this if there were doubt. They have actually seen and interpreted the data and know how to interpret it much better then we do.