I have owned this many times over the past couple of years, but adam F.'s article on thestreet.com made me cautious to buy it again, even at these levels, he offers a couple good points to ponder:
"all the lesions entered into the study were flagged as being possibly cancerous by dermatologists. This stacked the deck in MELAFind's favor, making it easier for the device to accurately diagnose melanoma....Despite the enriched pool of lesions entered into the phase III study, MELAFind still missed three melanomas, accurately diagnosing 172 of 175 lesions. This means that if MELAFind were the only tool used in these cases, three patients would have been told they were cancer free when in fact the lesions or moles on their bodies were melanoma."
---so basically this says melafind tested the prescreened data of those patients that doctors deemed worthy of biopsies and was able to determine (after the fact) that 97% of the time, no biopsy was needed. but it was WRONG 3 out of 175 times which means those three patients would have unknowingly left the doctor's office with untreated cancer.
given this information, speaking for myself as a fair-skinned person who has had a history of melanoma in my family and as a person who has had many biopsies in the past several years, i see melafind as an affirmation of a biopsy results, rather than a definitive opinion unto itself.
but perhaps it's a tool ripe for acceptance in an ObamaCare, rationalized health services world if not a device preferred by nervous patients and/or malpractice-wary doctors.
First, the study design and required endpoints were agreed upon with the FDA prior to the clinical trial, so the design of the study is a non-issue. The entire purpose of the SPA process is to avoid the problem you are insinuating here. The SPA was created so that the company making the submission and the FDA could agree AHEAD OF TIME, what data would be required and how the study would be designed to satisfy the requirements for approval. does this guarantee approval? no. But it does mean that the study design and endpoints are very unlikely to be an issue.
Aside from that you are ignoring the fact that the studies show that dermatologists are already missing 20%-30% of the melanomas, meaning that patients are ALREADY walking out of the dermatologists office with undetected and unbiopsied melanomas. That's the CURRENT SITUATION. With MelaFind, that would be happening significantly LESS frequently than it is now. The CURRENT SITUATION relies on patients continuing to keep an eye on suspicious lesions over time for continuing change and to have additional follow up visits. That will not change and will still be the case.
Ran across this copy from MELA's May 26th Press Release that confirms what I and others have said about the study design being a non issue. Adam F appears to just be trying to exploit the typical investors lack of familiarity with study design to cause doubt about the study data. This excerpt reiterates what we have known all along. The FDA has ALREADY AGREED that the design of the study would meet their requirements for approval.
"Prior to the start of the study, the company and the FDA entered into a binding protocol agreement to stipulate the study design, including the sensitivity and specificity endpoints that should be used to determine the safety and effectiveness of MelaFind. The company believes that the results of the pivotal study met and exceeded the pre-defined endpoints." - MELA's May 26th Press Release
The FDA's own document describes the SPA as intended to reach a pre-agreement on "clinical protocols for trials whose data will form the primary basis of an efficacy claim"
The FDA document is hard to slog through but if you want to read it for yourself you can see it here. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM080571.pdf
" dermatologists are already missing 20%-30% of the melanomas, meaning that patients are ALREADY walking out of the dermatologists office with undetected and unbiopsied melanomas"
is this a scientific fact? if so, it seems weird that melafind would design a trial that used only the data of those moles that were already deemed possibly cancerous i.e. biopsy-worthy. because melafind isn't proposing it's BETTER than a biopsy but it IS proposing that it's statistically nearly equal (along being with cheaper, quicker and non invasive).
so why not design the study to compare ALL moles (biopsy or not) that a set of doctors' diagnose versus melafind's diagnosis of that same universe of moles?
it seems to me, this would make more sense and would prove/disprove melafind's effectiveness.
as it stands now, melafind is only MARGINALLY better than a doctor at determining whether further tests (biopsy) are needed on garden variety moles and statistically insignificant with regards to the more difficult, borderline moles.
i am probably missing something here, and my premise is based only on adam f.'s article, which could be flawed as well. but at this point it's enough for me to back away for a bit
Fish, thanks for your analysis. I was getting a bit nervous and thinking about selling some of my substantial (relative to my portfolio) position in MELA, but now I feel a bit more comfortable. In particular, I agree that Adam's article attacks study design issues which does not make sense if this design was agreed upon ahead of time by the FDA. The general gestalt I got from his article is that he is biased, likely having some financial if not other form of conflict of interest. Doesn't anyone investigate and prosecute people like this?
It gave me, and several others, cause for concern also. They sold today at a loss and I bought more and have already made money on it. The company is growing in the market by having more shares available now. That makes it more attractive in the long run when the company value increases.
I am a physician who specializes in diagnostics (diagnostic radiologist). I can tell you that none of the imaging modalities we utilize has perfect sensitivity or specificity, yet the FDA had no qualms about approving ultrasound, MRI, CT, nuclear medicine, fluoroscopy, and conventional xray technology. There is also limited sensitivity and specificity to the hundreds of various lab tests that the FDA has approved.
The point is that the FDA will approve any diagnostic tool that is significantly better than the status quo, which I believe is the case with Melafind. Yes, Melafind will still miss a few here and there, but it will do better than dermatologists, and MUCH better than nondermatologist physicians, who evaluate many more moles than dermatologists. Dermatologists often have waiting lists that are months long.
Also, most drugs and devices that the FDA evaluates have potential side effects that factor into the equation. MELA does not. Thus the issue with MELA revolves strictly around efficacy and cost. The FDA approved the study design, so how could it be flawed? Using that design, MELA was found to be statistically significantly better than dermatologists. And I believe the dermatologists that they used were good. The average dermatologist is probably not as good as the ones used in the study.
Ultimately then, the issue is that of cost. There continues to be a huge push in medicine toward preventive medicine, not only to help patients, but to save health care money. Melafind falls into the category of preventive medicine. If the machine catches only a few melanomas in a given doctor's office per year that the physician would have deemed as benign (and visually atypical-appearing melanomas are not rare), the machine has paid for itself. Had those patients gone to develop invasive and possibly malignant melanoma, the health care costs would have been astronomical over the 6 months to few years of the remainder of those patients' lives.
Unless I am misinformed about the validity of the data, I feel confident the FDA will approve Melafind.
Disclosure: I own shares of MELA.
With cheap health care for everyone come
not perfect finding of MELANOMAS
all is good in a world where everyone
gets health care. Quality decreases as
number of people increase Obama
health care is for the masses but it means poorer
quality which makes for a great trading stock like MELA
In the context of MelaFind this makes no sense. We don't have anything close to perfect finding of melanomas now, even for those with very good insurance. Most dermatologists, including those who serve wealthy private insurance patients are trying to maximize patient throughput. I have very good insurance and went to a VERY highly regarded dermatologist that was personally recommended to me by a several friends in the medical field. His office visit was nearly comical. I felt like he was trying to set the world record for the world's fastest office visit.
While it may be true that if you try to serve twice as many patients with 20% more doctors, or even if you try to double the number of doctors over a relatively short period of time, the typical patient will be seen by a doctor with less experience ON AVERAGE. This has nothing to do with MelaFind which should, if it works as advertised, help less experienced dermatologists detect melanomas as well as the top 10% or dermatological specialists.
Mela CEO Gulfo cited data showing that it is 22 times more expensive to treat a late stage melanoma than an early stage melanoma. Even if you set aside the mortality, which is of course not inconsequential to the patient, MelaFind should have little trouble getting approved for reimbursement based solely on cost effectiveness, although that will take at least 2 years.
Something is seriously wrong when all you receive is one delay after another. One excuse after another. And idiot posters like Fish who try to placate your well deserved concern just a little while longer.
Not too shabby an observation Fncydansir.
When there were additional questions and no panel date then perhaps concerns were "well deserved" and the market reflected that additional concern but even then the market was betting on eventual approval, otherwise the shares would have been trading a lot closer to cash as you have been so fond of pointing out. Now that th delay is behind us, the concerns are just garden variety concerns like those experienced by even the best positioned products going through the FDA approval process.
As far as delays, there has been one since the PMA was filed and that has been dealt with. It's telling that insinuating additional delays that haven't really occurred is the best you have to offer.
An AP article put it this way
"Boenning & Scattergood analyst Greg Chodaczek said... the review date alleviates concerns over the FDA's request in March for more information on the product".
The recent burn rate did not include ramping up of expenditures in preparation for imminent commercialization. When they announced the additional FDA questions in March they specifically said they would be scaling back on their planned efforts in that area until those questions were resolved. Those questions are now resolved and we now have a Panel date so presumably that ramping up process and the related spending has resumed as well.
I believe the Street.com article alluded to a MELA CC that took place on the Tuesday when the secondary was announced but there is no link on the MELA website and I saw no announcement of any such call. TheStreet.com article itself is speculation so he is not in any better position than we are to know.
Bream Murray downgraded MELA saying that the "FDA is unlikely to have a panel hearing in 2010" when the FDA had said that a response to their questions would restart the 180 day clock. The Adam F article's speculations that there are issues with the study design likewise fly in the face of the known facts. There was an SPA in which the FDA and MELA agreed ahead of time about the design of the study and the endpoints. Adam F's article is based on speculation that ignores the facts that we do have.
What I truly find amusing about individuals like Fish is that they will pontificate about everything from secret internal documents, inside secret FDA proceedings, how the product will be marketed after (not IF) the product is approved etc.
The hysterical part is that these morons know NOTHING about what is truly going on behind the closed doors of the company and the FDA. They just want you to desperately believe that they know what they are talking about (to the point of lying about family involvement in medical trials and brothers who are employees of the company who possess special insight).
What a bunch of losers. Any you actually believe that readers take you seriously?