from the last 10-Q........
If we do not receive FDA approval to distribute docosanol cream as a prescription product or if we determine that the time
and cost to obtain approval is excessive, then we will likely be forced to pursue one of two alternative strategies. One
alternative is to find a development partner to share in any further development costs to obtain prescription approval. Another
alternative is to develop and market a modified formulation of our product to meet the FDA's guidelines for an
over-the-counter product for cold sores. We believe both of these alternatives will be more costly and will cause further delays
of any potential product launch for docosanol cream, when and if there is a product launch.
Do you know anything about the history of product development at ProCyte? They also got permission to sell a product, after having it declared non-approvable as a prescription product.
This is an excerpt from their 1996 10-K........
In August 1995, ProCyte submitted a 510(k) pre-market notification to
the United States Food and Drug Administration (FDA) for clearance to market
Iamin-Registered Trademark- gel in the United States as a topical gel for the
care and management of chronic and acute wounds. The FDA granted ProCyte
clearance to market this over-the-counter product in February 1996 for all wound
types with the exception of third degree burns.
Big splash, "FDA approves ProCyte product for.... blah, blah, blah". Trouble was, the *drug* had been rejected, but the *procuct* had been approved. It was just another dressing.
Here's their ten year chart.......
iqc.com
AVNR's chart would have some similarities, but the company changed their name to prevent people from drawing ugly lines like that.
Without the benefit of physicians, writing prescriptions because they were convinced of efficacy, their sales last quarter, two years after approval, were $827K. This is a well-managed company that actually still had a full complement of personnel. They weren't involved in a lawsuit with the ex-CEO, and they actually had some cash when the bad/good news from FDA hit (cash, cash equivalents and short-term investments of approximately $38.5 million as of 9/30/95).
How many products, *drugs*, are first approved for over-the-counter sale? Is it possible that this will be a 510(k) application? If so, what will drive price? What leverage does the company, which is broke, have with which to make a good deal? What does the competitive landscape look like now? What will it look like in five years?
This is Lidak by any other name. LDAKA. There has never been a company that has been a bigger blemish on biotech.
>> Look at the volume for today and you'll see they're snapping up cheap shares <<
Been going on for years, and the company's proponents have always been calling them cheap shares. I know the names of the individuals who start these pump and dump schemes for Lidak. Do you?
I have a sincere interest in investing in this overhyped piece of garbage if you can convince us that there is actually a viable business plan going forward.
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