Hi Wolf and threadsters,
The recent president's message and yesterday's RobTV interview has filled in many of the blanks. This reduces risk imo. I have pasted my notes from the interview below (sorry its messy) and after thinking overnight, a few comments. No too bad for a QA session with 8 Qs and A in 8 minutes. I liked the "ask the CEO with s/h email" format.
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one on one viewers ask management
Overview - drug delivery product and focus on Pennsaid
Q1. status w/ JnJ and timing, distribution with the usa.
based on agreement cannot comment, still on track not diswayed from choice of partner
Q2. outstanding items for FDA approval process.
FDA act proscribed from discusing interactions
dialoge continuing
She uis positive for both Canadian and USA submissions
{Next Q&A, she mentions that FDA plant inspection has not been scheduled yet. A slip? I was going to move forward my expectation for FDA approval to the summer based on the NA launch comments and rumours. But with this statement, I'll leave my expectations for an autumn/end of calendar year approval.}
Q3. Canadaian and plant inspection
canadian and euro plant inspection done
us plant insp has not been scheduled yet
{This is revealing}
Q4. able to issuance of company targets
clear targets is in the EU
product approval in other member nations by second half of this year
expecting Canadian this year
Cdn Gov reviewed plus additional request for info , not in our control
preparing for Canadian launch
{This clarifies the preparation for NA launch is Canada, not US (or Mexico <gg>) }
Q5. market potential
cox2 celebrex and vioxx
5billion 40% of market
10% oa taking oral, nsaid - drug interaction, side effects
target just 10% = significant
{This was big news to me. First, Rebecca is now using COX2 actual sales $$, before its was NSAID numbers and estimate of market size. COX2 have captured an actual $5B USD of an estimated 12.5B market. I'll bet she will be using this when talking to new partners. Second, the 10% number!! These are OA people suffering pain that cannot tolerate the so called ""safer, easier to stomach"" COX2 pills.
For my own DD, I was using what each % of $5B USD would do for our revenue line and set an initial max of 5% based on good arguements from people on this board. Now I'll move it up a notch to 10%. I'll leave the $5B for now (its published numbers, I know the markets larger with the traditional NSAIDS) until several quarters of earnings are out or if some one has a good arguement on expanding market with the safer new products.
Based on another recent SI post, the additional Celebrex studies for the recent proposed label changes appears to be tainted. Upwards of 25% of people rejected for inclusion in the study, then 10% of study population suffers side effects. I take this as an opinion and not fact at this time until a publish document can be produced and posted. But I like it!}
Q6. management team have the experience skill max potential of company
issues addressed
become fully integrated
mission to market
transition essential to put in place internal structures
r&d to commercial costing taxation transfer prciing
teams internally can deal with this
substance and structure in place
confidence ever since purchase of facility
{Rebecca acknowledges this as an issue. She did not do the lawyer response, it was very clear to me. She did try to assure that teams can deal with the changing business.}
Q7. stock price- additional financing- cash levels
flexibility
jan pp with 50mm Cdn equity line, did one draw down
very flex innovative, draw down when we want
no penalty, but over 13 month
cash is not an issue
700-750k /month cash burn
{The 700-750 cash burn was expected. In DMX terms that's the overhead expenses. What is not said is how much is needed for inventory and plant and capital expansion/improvement.
But I agree, cash is no longer an issue for the next 13 months, given no big spending spree on R&D and new products.}
Q8. when trials anti fungal
now: preclinical with anti fung prep, method, formula
expect clinical start before calendar yearend
{Fungoff, I was hoping to hear about WF-10 and its expected phase III report. I guess I shouldn't bitch, I didn't have time to email in any questions.
Some one else did want to know the status of the anti fungal.
Hats off to the people taking time to email in the questions.} |
