Husky, I agree with the part about selling to other countries ASAP. I've heard the same that HHS is the main priority.
BCRX needs to explain the plain in more detail.
The Therapeutic Goods Administration (TGA), through the Therapeutic Goods Act 19891 and the Therapeutic Goods Regulations2, is responsible for the quality, safety, efficacy and timely availability of drugs and medical devices in Australia.
The Baume report saw great promise in a system which would allow applications to be assessed rapidly if evaluation reports were available from two acceptable overseas regulatory authorities (U.K., U.S.A., Canada, Sweden, Holland). That promise has not eventuated because many applications are filed simultaneously in Australia and in other countries, so overseas evaluation reports are not available.
we have the data from the FDA and Japan ready to go…so what are we doing? nothing...
i've got a six pack that says no SNS order till next winter. why? because the government can't think that far ahead (seriously). meanwhile, if we filed in the EU and Australia right now, we could be approved and selling product by next flu season. I understand that we are indebted to HHS for funding, but this is a publicly traded company. we're here to make money, not friends. BCRX's first responsibility is to shareholders not HHS.
Sovaldi was approved by the FDA on Dec.6, 2013.`4 weeks later, the EU approved it on Jan 17,2014. 5 months later Australia approved it on July 4th 2014.
"Obtaining a U.S. government stockpiling order for Rapivab is a priority over seeking approvals in other countries. "
we're "too busy" to file P for approval anywhere else…yep, "BioCryst is by no means solely dependent on government funds to run its operation or develop its drugs for orphan diseases."
it's solely dependent on shareholders wallets…
"The biggest red flag with BCRX has been its underperformance and stagnation when the IBB has been surging to new highs."
Yui, BCRX would have surged if not for the continued growth in the short position from 10 mln to 14 mln. To absorb that amount of short pressure and hold in the 10-11 range I think is impressive.
Babu selling didn't help along with a couple cramer attacks which broke the 10 resistance. Now the correction of the IBB is putting a lot of weight on the pps adding to unjustified (but understandable) "fear" of investors.
Considering the recent push down I would say selling volume of shareHolders has not been that high. All those who shorted the stock still need to cover.
DYAX data may have impact as it comes out here in the next week or two. Stonehouse made it clear to watch for how they compare the data to skew it towards benefit. The trial is a small PH1b comprising of 30+ patients.
It's my opinion that those who hold a large short position hoped for multiple reasons to create selling and never got one (besides Babu and cramer). The DYAX results likely will be "good" but shouldn't rattle BCRX that much and Stonehouse has preempted potential comparison efforts of DYAX trying to make themselves look better than they may be. Pushing hard on the PPS can be effective to create selling and that's what I think is happening.
Babu sold a bit in 2009 just before the stock imploded. As far as I can remember, other insiders were not selling at that time.
He also has been selling lately in the 10's (the past month or so) which so far, looks to be the right decision. He was the only insider who was really selling. Someone new to the company bought 10k on the open market at $10. If you followed that insider buy, you're underwater. If you followed Babu and took profits, you're feeling good right now.
The biggest red flag with BCRX has been its underperformance and stagnation when the IBB has been surging to new highs. Now that the IBB is weak, it looks like it's taking BCRX down through support levels since buyers have dried up (or shorts are just too strong since the sector has attracted a lot of shorts).
Watch $7 as it's key in the intermediate term on a technical basis. That's my place to begin selling puts with implied vol getting up there. I'm a big fan of this company, particularly the HAE platform. Remember: Stonehouse has sold NOTHING even though he has a great deal of gains (and shares). That's extremely rare and means 1 of 2 things: 1) He's completely delusional and greedy or 2) He knows what the company has and is willing to wait it out (along with the Baker Brothers).
Let's see what happens with the DYAX data. GL longs.
Can bounce now (tomorrow or next week). Dropped enough for shorts to start covering some.
Sorry frustration talking. I figured an end of day puke in the market would pull this in to the 7's.
Feel taken by the cruddy follow up to the end of year positive press.
Goldman trimmed to what? Sell? What did they trim their price target to? $7? They always tip their customers or move money out ahead of time. That's how the big boys do it. Mr retailer gets wagged.
Stoney owes Shareholders an announcement, make a deal, work on the revenue side or hire someone who can. IMO
Can't argue the logic on the downward pressure.. Give me back my 10.50 and I'll be good to go short of a stocking order or pharma or government partnership to distribute.
I can wait. Not sure double digits come without the above.
Summary of Data Changes
Integrated OCE v 16.1
Effective April 1, 2015
The following APC(s) were added to the IOCE, effective 04-01-15
09451 Injection, peramivir
the official short interest at NASDAQ dated 3/13/15 12,029,612. since then, i believe it's back to 14mil.
yesterdays count - 342,000 long ----235,000 short.
what's going on? well, the boys (shorts) were overextended. so, they started a cascade by shorting one day at 80% of the trades, breaking down the T/A and now were in a free fall. indexes are now doing the work that the shorts did…it can't get any worse, can it? FUD is growing, and that's where weak hands also that helps the shorts…no new news expected for months…let's see, what else…
oh yeah, TELL ROB TO ANSWER MY E_MAIL. here's what it says…
Dear Mr. Bennett, Can you explain to me the wisdom of running a company solely dependent on government funds?
now, after somebody tells me "oh, oh, we're going to look for a partner!" well then, then the annual report put out just 3 weeks ago looks like this…
RAPIVAB was approved by the U.S. Food and Drug Administration (“FDA”) on December 19, 2014 for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days. In December 2013, we submitted a New Drug Application (“NDA”) which contained data from over 2,700 subjects treated with peramivir in 27 clinical trials. We have made RAPIVAB available for commercial sale through agreements with specialty distributorships during the 2014-2015 influenza season. Our current focus is to obtain a stock-piling procurement contract with the U.S. Government to realize the strategic value of this program.
THIS SHOULD BE ADDED…OR SOMETHING LIKE THIS….
Afterward, we intend to partner or outsource distribution, and sales of RAPIVAB to other governments or health care centers through out the rest of the world, so we can realize the full value of RAPIVAB.
because it's a fundamental structure to the long term health of the company…
the minute i'm green - which will happen, but not for a few months, I'M OTTA HERE...
Always do the opposite of the mainstream. All the big institutions giving inflated price targets and since then the bottom has dropped out. Ot also appears that Stonehouse and company has underwhelmed at recent conferences .
On a positive note, a recent new hire had nice things to say about the company and another person thinks these guys are the real deal. All that matters though is the PP and that has been gouged in the past couple months.
I will wait to see if the option volume picks up to renter the stock. It is in no man's land at the moment.
If news was out, that's one thing, but without any news, or I should say any "public" news, this is just not good. All the recent pr says this should by 4, 5 points higher, not lower. Any board vets have any insight to the last week of pps activity?? TIA
"All programs are on track"
FYI, BCX4430 has been reviewed by NIAID prior to continued funding. We don't know how many dose adjustments the trial has been through yet but before each one there is a review of safety. As you know, the project is funded and PH1 to complete 3Q...estimated funding by BARDA before then. Estimated value is 700 mln to 1 bln. NDA projected 2016.
Rapivab: Dist. Partner and stockpiling order in the works, timing unknown.
Responses to RFI for tamiflu and relenza were back in Feb
The United States Department of Homeland Security (DHS), Office of Health Affairs (OHA), requires antiviral medications for a highly pathogenic outbreak that could lead to a pandemic. DHS was appropriated funding in accordance with PL 109-148 for the preparation, planning and mitigation of a pandemic influenza. DHS has been closely monitoring the effectiveness of pharmaceutical interventions as a part of its overall pandemic preparedness plan. Additionally, DHS has been working closely with the Department of Health and Human Services (HHS) with regards to antivirals, and the pre-positioning of antivirals in the Strategic National Stockpile. DHS OHA has oversight and planning responsibility for all DHS components with regards to the DHS Antiviral Stockpile.