Hi Russet
Reviewing my notes, Rebecca responded to that Question.
1. issues should have been dealt with labelling
2. answers to all their issues raised already in the documentation provided
The first part.
From where I sit, Rebecca did provide a clue. Some of the issues should have been dealt with after an approval, perhaps in the labelling stage. I hope I interpreted correctly that labelling happens after approval, in light of the overall process. Please correct. Warren, Mark??
IOW, some of the issues were miss classified or should not have been raised at this time to warrent a NON.
The second part, is what you are asking. Same as what the interviewer was trying to pry from Rebecca.
I can't talk for Rebecca, but can only offer my opinion. To the rescue, Zorro.
1. From where I sit, I assume Rebecca knows these types of interviews are interested in only in short, quick, bottom line answers. Interviewers are known to cut off or switch quickly to another subject. Really no time to chit chat and shoot the cheeze. Rebecca, 2 points.
2. I assume, that the issues could be technical. So its good she didn't say. Finance People don't understand and really don't care. They only want to know if its significant, show stopper, fatal, or what $ impact.
And Rebecca did indicate the issues were insignificant. Rebecca, 2 points. Of course that's her side of the story.
3. From the flowchart Warren dug up from HC, one box in the process has a clerk finding shelf space and unpacking the crate of documentation. This paints a picture of the size of the submission. So, the issues could be the "T"s or "I"s anywhere in the 1000s of pages of documentation. ROBTV is really not the forum to chat.
4. I recalled several ROBTV interviews with junior Biotech CEOs or presidents where the interviewer asked similar question for clarification, or asked for explaination of some scientific quirk. These CEOs were so square ,they actually gave the long winded 'scientific answer' and the funniest one was a guy trying to give a demonstration of a device to answer a question raised to him, but the device didn't work. Guess it wasn't plugged in. Doh! Total embarassment on 'prime' time TV. Rebecca, 3 points.
Rebecca is not the only female to head a junior biotech, but she is the most poised, good presence, professional and articulate.
5. For example, I posted a 1 in 5000 chance of a drug moving from preclinical to commerialization. Anyone can challenge me how I got that number.
I also posted the source and how I derrived the answer. Chances are I won't be challenged.
Had I just posted 0.0002 as the probability, nothing more. I should have been challenged.
I assume, and its probable, something of this nature is being challenged in the pages of documentation. If it is, I hope its not in the FDA documentation. Being an open dialogue with the FDA, I suppose DMX can easily explain. From an objective point of view, if such an issue has happened, then DMX needs to learn and fix. Rebecca, penalty box.
Anyways, filler time.
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My notes, if anyone can make use, else press next. Disclaimer is assumed!!
robtv.com
RobTV After HC NON compliancfe
Cold Stocks
price of DMX fell on news of
HC issued Notice of Non Compliance
I: Explanation of NON
RK:
Essenitally a decision in the review process
HC reviewd entire submission
many issues
Concluded they nnedd more information
90 days or more negotiate to respond to issues
upset us 1. is the tardiness; 137 days beyond own guidelines
2. the use of notice of non compliance
issues could have been addressed with data provided
practically using NON shuts off the time clock
Glob and mail article end of Jnauary
significant of deficiency
worst record in the develop world
issue of NON stops the clock improves their statistics
I:How often? Common?
RK: very common, Article an example RA drug 985 days past own
dedline
every other country approved before HC
I:Issues? What are issues hc they reasoning, citing requiring?
Isues should have been dealt with the labeling
issues; answers are in the documentation already provided
globe mail hc= risk avoidance, inaction, fx of lack of expertise
don't do, thereforecan't be critizied
position from HC reflects all of these
I:FDA; does it mess up on that end
RK: no; doesnt impact with the FDA
complete contrast
open collaborative
clearly the expertise at the FDA to review the dosier
collab,dialogue with them
very confident receive aproval in a timely
I: Share holder knocked the stock down
Do u Sense s/h geting impatient
down the last couplue of year
RK: yes, understatnds the frustration
Frust not only on the shareholders
Frust carry over to OA suffers
conducted studies onver the years
patients, thous contact us , want to know when they get P
Stats Canada
1900 die per year taking oral medication,
using this eexample 137 days; 700 have dieed
P may not have save alled 700, if
saved one life would have been worth it
frustration with shareholders wt delay
encoruaged with the FDA
light at the end of the tunnel
I:Dialog around the regulatory issues
financial issues
Acqua Wellington
Why advantagous vs stand equity offering
RK:
- limited to timing, based on Bankers timing
= Banks feel window is open to you, open t o whole sector
- going with the herd
- may not be the right timing for us
= take as much money when ever wer want
- control
- down side no ananlyst coverage
- happy w flexibility it afords
I:Profitability, when?
RK:
share price
event driven, 2 events s/h
completion of agreement with distributin partner in us
and fda approval
targetting inthe USA 8 billion market
generate and drive revenue and drive share prices
launced in a number of markets
upfront with licencees
us and europe
bring P in number o eu
year of flux transtition from RnD to commercial
predictability of profitabliuy
know where we are going
HC is a disappointment but will not prevent us from our objectives |
