A preliminary decision will be made in 60 days since Nov 1, so somewhere in the end of Dec. After that it will take from 6 to 10 months. Since Zelrix is not based on a new chemical, but just a new delivery method for an existing drug, I think the time to approval will be at the lower end of this range.
The IR person just told me that they expect to bring the product to market in the beginning of 2012, so they are working under the same time line that I am posting here, padding the estimates a bit for safety.
Here's a summary of my interview with the IR person:
Q: What's your opinion about the extremely low buying volume on the stock? A: The main reason is that the buy-side analysts that we (PATH) had talked to say that institutions tend to hold off buying low-volume stocks like PATH near the end of the year, since they need to keep their holdings and return numbers stable in preparation for the year-end report.
The other possible reason that we can't confirm precisely is that there may be some selling for tax (capital loss) purpose, due to this being near the end of the year.
Q: What's your opinion about promoting stocks more to retail investors using online channels, facebook, etc? A: We can't actively do that ourselves, due to SEC regulations.
Q: What are the steps that are being taken to heighten awareness about Zelrix in general? A: We are trying to hold off on heavy marketing effort until the NDA application is approved, to limit the cash burn rate.
Q: Could you confirm for me the Net Tangible Asset Value of the company? A: *digging through the SEC filings* As of end of June, it would be 51M cash equivalent. (current market cap being around 80M)
Q: Could you confirm for me the price at which preferred shareholders converted into common after the IPO? A: That would be around 6.19. The net tangible asset value calculation was marked as pro forma, since the conversion happened at the time of IPO in august, but the latest balance sheet data was for the quarter ended in June, so the effect of the conversion to NTAV was applied to end-of-June's data.
There are other small things that I talked about, but not directly related to the stock's movement. I discussed a bit about the language and presentation of PR material, and what could be improved about them. He also pointed me to sources where I could find prescription-filled data on the other sumatriptan products so that I can do my own projections on the sale of generic sumatriptan products, and Zelrix, when it comes out.