RE: Mela comparison
Not for sale yet ...
Not Quite "Yes," but Close Enough
The FDA has not given the company the green light to start selling the MelaFind device yet. What an approvable letter means, in essence, is that the FDA finds that a device is more or less approvable as is but there have to be some additional changes to labels, user guides, training, and post-approval trial guidelines. Importantly, these issues never require a second clinical trial to resolve and I cannot immediately recall an example in the last 15 years where a company and the FDA were not able to resolve these issues and go from "approvable" to "approved."
In other words, while the company will not begin shipping MelaFind to U.S. doctors on Tuesday, the finish line is very much in sight.
Can MELA Sciences Get the Sales?
Now the question shifts to whether or not MELA Sciences can make a business out of this device. Remember, approval does not guarantee favorable reimbursement, nor does it guarantee that doctors will buy and use the device.
The best analogy to MELA Sciences and MelaFind may be the implantable vagus nerve stimulation therapy sold by Cyberonics (Nasdaq:CYBX). While VNS therapy has been accepted by clinicians and payors in epilepsy, the company has had much less success in depression. The FDA ultimately granted approval for VNS therapy for severe depression (after a battle not unlike MELA's battle for approval), but neither insurance companies nor doctors have shown much enthusiasm for the product in depression.
Remember, the medical device industry is not always a "build it and they will come" industry. Companies like Abiomed (Nasdaq:ABMD), Given Imaging (Nasdaq:GIVN), Atricure (Nasdaq:ATRC), Spectranetics (Nasdaq:SPNC), and Hansen Medical (Nasdaq:HNSN) have all had FDA approvals and have still struggled to build sustainable growing businesses.
In the case of MelaFind, those final details on the labeling, training and marketing guidelines could make a difference in whether or not physicians buy the device and whether they use it regularly. If they buy it and just keep it on the shelf, the stock isn't going to work as well as the bulls hope. Likewise, significant adoption and use could rest on the outcome of those post-approval studies - MELA bulls may argue that using the device can't hurt anybody (and that docs can still rely on their own judgment to supplement the device), but in a cost-conscious and litigious health care environment, that may not be enough.
The Bottom Line
MELA shareholders should enjoy their victory lap today, as the company has seemingly managed to do the highly improbable and secure an approval from a clearly hostile FDA. While approval is clearly better than rejection, the next argument on the stock is going to revolve around the true market potential for the device and how much the company will have to spend to get doctors to use the device and insurers to pay for it. There's clearly a market out there for a dermatological tool like MelaFind, but MELA shareholders need to realize that the uphill climb is not over yet and there's still a lot of Wall Street skepticism to surmount before the stock can really get moving.
https://stocks.investopedia.com/stock-analysis/2011/MELA-Gets-A-Surprising-Yes-MELA-CYBX-ABMD-GIVN-ATRC-SPNC-HNSN0926.aspx?partner=YahooSA#axzz1ag1Iplph
Not Quite "Yes," but Close Enough
The FDA has not given the company the green light to start selling the MelaFind device yet. What an approvable letter means, in essence, is that the FDA finds that a device is more or less approvable as is but there have to be some additional changes to labels, user guides, training, and post-approval trial guidelines. Importantly, these issues never require a second clinical trial to resolve and I cannot immediately recall an example in the last 15 years where a company and the FDA were not able to resolve these issues and go from "approvable" to "approved."
In other words, while the company will not begin shipping MelaFind to U.S. doctors on Tuesday, the finish line is very much in sight.
Read more:
https://stocks.investopedia.com/stock-analysis/2011/MELA-Gets-A-Surprising-Yes-MELA-CYBX-ABMD-GIVN-ATRC-SPNC-HNSN0926.aspx?partner=YahooSA#ixzz1ag1rLeeq
Not Quite "Yes," but Close Enough
The FDA has not given the company the green light to start selling the MelaFind device yet. What an approvable letter means, in essence, is that the FDA finds that a device is more or less approvable as is but there have to be some additional changes to labels, user guides, training, and post-approval trial guidelines. Importantly, these issues never require a second clinical trial to resolve and I cannot immediately recall an example in the last 15 years where a company and the FDA were not able to resolve these issues and go from "approvable" to "approved."
In other words, while the company will not begin shipping MelaFind to U.S. doctors on Tuesday, the finish line is very much in sight.
Read more:
https://stocks.investopedia.com/stock-analysis/2011/MELA-Gets-A-Surprising-Yes-MELA-CYBX-ABMD-GIVN-ATRC-SPNC-HNSN0926.aspx?partner=YahooSA#ixzz1ag1rLeeq
Not Quite "Yes," but Close Enough
The FDA has not given the company the green light to start selling the MelaFind device yet. What an approvable letter means, in essence, is that the FDA finds that a device is more or less approvable as is but there have to be some additional changes to labels, user guides, training, and post-approval trial guidelines. Importantly, these issues never require a second clinical trial to resolve and I cannot immediately recall an example in the last 15 years where a company and the FDA were not able to resolve these issues and go from "approvable" to "approved."
In other words, while the company will not begin shipping MelaFind to U.S. doctors on Tuesday, the finish line is very much in sight.
Read more:
https://stocks.investopedia.com/stock-analysis/2011/MELA-Gets-A-Surprising-Yes-MELA-CYBX-ABMD-GIVN-ATRC-SPNC-HNSN0926.aspx?partner=YahooSA#ixzz1ag1rLeeq
Not Quite "Yes," but Close Enough
The FDA has not given the company the green light to start selling the MelaFind device yet. What an approvable letter means, in essence, is that the FDA finds that a device is more or less approvable as is but there have to be some additional changes to labels, user guides, training, and post-approval trial guidelines. Importantly, these issues never require a second clinical trial to resolve and I cannot immediately recall an example in the last 15 years where a company and the FDA were not able to resolve these issues and go from "approvable" to "approved."
In other words, while the company will not begin shipping MelaFind to U.S. doctors on Tuesday, the finish line is very much in sight.
Read more:
https://stocks.investopedia.com/stock-analysis/2011/MELA-Gets-A-Surprising-Yes-MELA-CYBX-ABMD-GIVN-ATRC-SPNC-HNSN0926.aspx?partner=YahooSA#ixzz1ag1Vh3eG
Not Quite "Yes," but Close Enough
The FDA has not given the company the green light to start selling the MelaFind device yet. What an approvable letter means, in essence, is that the FDA finds that a device is more or less approvable as is but there have to be some additional changes to labels, user guides, training, and post-approval trial guidelines. Importantly, these issues never require a second clinical trial to resolve and I cannot immediately recall an example in the last 15 years where a company and the FDA were not able to resolve these issues and go from "approvable" to "approved."
In other words, while the company will not begin shipping MelaFind to U.S. doctors on Tuesday, the finish line is very much in sight.
Read more:
https://stocks.investopedia.com/stock-analysis/2011/MELA-Gets-A-Surprising-Yes-MELA-CYBX-ABMD-GIVN-ATRC-SPNC-HNSN0926.aspx?partner=YahooSA#ixzz1ag1Vh3eG