The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Steve Brozak - WBB Securities - Analyst
: Hey, good afternoon, gentlemen. I mean, we're watching a lot of things that are happening right now involving, how should I put it, swine flu and
this government's reaction as far as how a new HHS administration is coming in. We seem to be seeing a level of coordination. Are you comfortable
with the level of coordination that you're seeing that's now novel and the integration that you're seeing? And do you look at this as something
that's positive? Or, do you look at it as something that's a bit of a distraction? How would you characterize all of the interface that you've had over
the last, let's say, three weeks?
Question: Steve Brozak - WBB Securities - Analyst
: So one quick follow-up on that, so the coordination that they're putting forward now basically would make it more expedited and easier for you
once you do get the approval and would provide for a seamless transition as far as contracting into the future. Is that a fair assessment?
Question: Steve Brozak - WBB Securities - Analyst
: Okay, thanks. I'll jump back into queue.
Question: Elemer Piros - Rodman - Analyst
: Good afternoon. Can you hear me, please?
Question: Elemer Piros - Rodman - Analyst
: What I'd like to ask is do you have a sense, since there is no formal action time set by the FDA, did they give you an indication that -- how long
would it take for them to provide an opinion on your proposal?
Question: Elemer Piros - Rodman - Analyst
: So, you know it's precisely where this proposal would have to be submitted? You know who might be reviewing it and to what level of satisfaction
you would have to reach for BARDA to be satisfied?
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APRIL 29, 2009 / 8:30PM, ALT.OQ - SparVax rPA Anthrax Vaccine Update
Question: Elemer Piros - Rodman - Analyst
: Okay.
Question: Elemer Piros - Rodman - Analyst
: Okay.
Question: Elemer Piros - Rodman - Analyst
: Okay. Thanks, for clarifying that, David.
Question: David Moskowitz - Caris & Co. - Analyst
: Yes, thanks for the question. The first question actually is on the delay that we initially saw by HHS. I'm a little puzzled about that. Initially, we saw
a -- I guess, statements that there would be a 15-day delay and that was pushed into June, or mid-June, so can you talk a little bit about why there
was a change? And again, I had thought that the companies that were applying for rPA had been in talks with HHS and BARDA. Clearly, the contracts
that were being negotiated would have milestones and a protocol in there. Otherwise, there'd be no way to determine when future payments
would be dispersed. So, I'm a little unclear number one on the timing pushback and why all of a sudden the protocols need to be vetted when
they should have been very well vetted for what I would think to be a very large and important contract, over $1 billion.
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APRIL 29, 2009 / 8:30PM, ALT.OQ - SparVax rPA Anthrax Vaccine Update
Question: David Moskowitz - Caris & Co. - Analyst
: To follow up on that, but the -- I guess my question is why would they come to you guys and say that they -- that there's a 15-day requirement and
then come back and revisit that if -- when they had come to you and perhaps and any of the other companies that are involved in the RFP would
say that, "We're fully prepared to submit that at the current time."
Question: David Moskowitz - Caris & Co. - Analyst
: Okay. I have a question about the data that you guys had put out yesterday on SparVax versus BioThrax. There's a component of the release, the
presentation, that says that the product, that SparVax, is superior in terms of tolerability. And it says in the press release on the then dosing regimen
for BioThrax, which is sub-Q, I understand that the way BioThrax is now given is IV, so can you comment on any tolerability comparison that you
have between SparVax and BioThrax based on the current regimen, or current administration, protocol for BioThrax?
Question: David Moskowitz - Caris & Co. - Analyst
: Okay. But once again that was on the earlier regimen of BioThrax, not the current regimen?
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APRIL 29, 2009 / 8:30PM, ALT.OQ - SparVax rPA Anthrax Vaccine Update
Question: David Moskowitz - Caris & Co. - Analyst
: And just another question on the development of SparVax. Could you tell us how long it might be until we could -- until you guys could get to final
dosing batches of the product and how long it would take to demonstrate stability for the product? Let's say three years stability, which is what
the current anthrax vaccine has on the market?
Question: Matt Duffy - BDR Research Group - Analyst
: Good afternoon and thanks for taking my question. Dave or your team I wonder if you could just maybe give us a little more color on what the FDA
review of your plan may look like? Are you planning on submitting things as detailed -- full protocols for future studies and validation processes
and all of that?
Or is more of a top line, sort of, this the road map of what we'll be providing you over time? And then as they look at that do you expect this to be
a fully iterative process where you expect to go back and forth and back and forth? Or is it a review where they give an opinion and then BARDA
takes it from there and you provide a response, if you could help me with that?
Question: Debra Fiakas - Crystal Equity Research - Analyst
: Thank you. I just wanted to clarify the data that you're presenting at the meeting, actually, going on this week, the conference on vaccine research,
that is from your second Phase II trial for SparVax and the data that was presented earlier this year in February at biodefense meeting that was from
your first -- the first of the two Phase II trials?
Question: Debra Fiakas - Crystal Equity Research - Analyst
: All right, and then if I could just add a follow-up question, to the extent that you can, can you describe what your current development activities
are with regard to SparVax during this somewhat interesting time as you're awaiting for this contract award, could you give us an idea of what
you're working on now?
Question: Jeremy Gorlich - - Analyst
: Hi guys. Jeremy Gorlich, Gunal. Some of my other questions were answered on recent phone calls, but one in particular, which I've been preaching
to the choir because I've been talking about it for four years, three years roughly, since the inception of this deal, the first thing, David, in your gut
feeling you've been doing this a long time. Do you expect this and I understand what the FDA says and they go back to you, but we've heard this
before. Do you expect this to be a six-month, a year thing, 12 months, you know, in your gut feeling knowing the experience that you have how
do you think this process can realistically take?
Question: Jeremy Gorlich - - Analyst
: Okay, because that would shock you if it went beyond three months?
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APRIL 29, 2009 / 8:30PM, ALT.OQ - SparVax rPA Anthrax Vaccine Update
Question: John Brady - DMR - Analyst
: Hi, David, how are you doing?
Question: John Brady - DMR - Analyst
: Just to follow up on what Jeremy Gorlich and based on your good feeling, three months, if that were the case there are a lot of warrant holders
that are out there. Has there been any talk about extending the exercise date, the expiration date on those warrants or are they still said to expire
in July of this year?
Question: John Brady - DMR - Analyst
: Yes.
Question: Doug Weede - Advanced Equities - Analyst
: Well he just answered one of the questions. Two quick ones, number one, you'd indicated that the contract was for 25 million doses. I've been
hearing that they're talking about two 25 million dose contracts, number one. And number two, can you tell me how many people are in participation
of the bidding at the present time, how many companies?
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APRIL 29, 2009 / 8:30PM, ALT.OQ - SparVax rPA Anthrax Vaccine Update
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