You can judge the significance of the announcement by the number of shorts falling over themselves to post negative comments (lol).
Unilife invents a technologically-elegant device to address the burgeoning diabetes market and shorts are telling us it's a bad thing. Lol
Just so we stick to the facts, Alan was one of 13 nominees, not 30. The 13 categories, included Distribution and Manufacturing (Alan), Emerging, Energy/Clean-tech & Natural Resources, Financial Services, Health Care Services, Life Sciences, Retail & Consumer Services, Services, Technology, Social, Family Business and Philadelphia transaction. ... but I guess facts aren't that relevant to you.
In addition to the six known device categories (Pre-filled Syringes, Reconstitution Systems, Auto-injectors, Wearable Injectors, Occular and Novel Delivery Systems) Alan twice confirmed the existence of a new category (a 7th.), which has yet to be disclosed, but will be announced in the future. He then mentioned that several pharmas had interest in the device(s)?
Oh, my apologies. I didn't understand that you were on a mission of mercy to help newcomers avoid the mistakes you made. Well, here's my tip to newcomers. Read all you can on the shifting landscape of home-administered biologics and other drugs. Learn how many companies are looking to protect and grow their marketplace by differentiating their drug delivery processes. Study the competition. When possible, learn which competitors's syringes are being used by pharmas. Take time to study Unilife's entire portfolio, paying particular attention to ant high-tech advantages Unilife may offer over their competition.
If not already aware, become knowledgeable of the steps required to bring a drug to market; proof of concept, Ph1-3 trials, usability studies etc.
Read every article, every blog and listen to every relevant presentation. Be critical and trust your common sense. Beware of those who are consistently "pie in the sky" or alternatively are always negative. Toss out those who resort to name calling, as they either have a personal agenda or are attempting to annoint themselves as the "wise one." Discount posts that are scary or warn of impending doom as they are speaking to your emotions.
I'm not naive enough to think that Unilife's syringes are the right fit for everyone. Some pharmas may feel they want/need all the bells and whistles to differentiate their brand. Others may feel fine with a more scaled back version. I think their decision on how they market their drug depends on who they are marketing it to; what the competition offers and cost. Don't think there's one device that fits all. In full disclosure, reading (and re-reading) Indijo1's posts over the past 2 years have given me a much better understanding of the market and Unilife's competitors.
Presumably, Regeneron's partnered with Sanofi to leverage their marketing abilities. In supporting Unilife as they have, I believe Sanofi would also seek to leverage Unilife's unique capabilities as a known quantity.
Itsa75, I share your sentiment. Everyone seems to be hinging their hopes on a near-term deal with Abbvie, perhaps belying the hope that they can come to the rescue. Maybe, who knows. I personally think there's a better chance that something with Sanofi/Regeneron will eventually shift the needle.
Apparently Karl apparently believes me to be the mad ramper. Personally I think many get tied up in every up and down. I don't. If I had owned UNIS for 10+ years as many have, I'm sure I would be wrapped up in knots and the seemingly endless horizon. But I haven't owned it for 10 years. I've owned it for a little less than 3 and I am prepared to see what happens in the coming 12-18 months. We're told that these deals take up to 3 years, from signing to production. We're getting close to that on some of the first deals. I'll wait and see. If I'm wrong, I'm wrong, but I don't think I am.
One thing I won't do it whine about my decisions incessantly... How many months has it been Karl. I know you've been around for the ride from $2.75 to $5.80 and back again. Frankly, I'm tired of hearing how you shoulda done this, or that and how evil those are who fooled you or don't agree with you. Keith didn't place your order for you. Neither did Alan. You did. You did. You did. Get over yourself!
Itsa75, I don't think I know any more than you. At this point, seems all that can be said with confidence is that the Sanofi/Regeneron partnership is producing impressive results with known and potential drugs. Obviously the hope is that our long-standing relationship with Sanofi will tilt the scales in Unilife's direction on one or more indication. A connection with one or more of the candidates (Alirocumab, Dupilumab, Sarilumab or Eylea) would be a boon, as each has, or could potentially have, blockbuster status. Even if Unilife only bats 250, it would be significant IMO. To quote Donald Rumsfeld, "there are things that we know we don't know. But there are things we don't know we don't know." I try and ignore the day to day push and pull (though I would be lying not to say there are days I wonder). I have no interest in rehashing Alan's past statements of exhuberence (though I can certainly understand the resentment a long-term holder might feel). To the extent possible I try to isolate where the company stands now, what recent moves have been made and the likelihood of earler announcements yeilding revenue in the months ahead. Factoring in all of the above, I am betting that Alan and his newly-formed team will pull some rabbits out of the hat in the balance of 2015. It is a bet though... hopefully moderately researched, but a bet nonetheless.
NOTICE OF SPECIAL MEETING OF STOCKHOLDERS
TO BE HELD ON WEDNESDAY, JUNE 17, 2015, AT 4:00 P.M. U.S. EASTERN DAYLIGHT TIME
(6:00 A.M. AUSTRALIAN EASTERN STANDARD TIME ON THURSDAY, JUNE 18, 2015)
TO THE STOCKHOLDERS OF UNILIFE CORPORATION:
Notice is hereby given that a special meeting of stockholders of Unilife Corporation, a Delaware corporation will be held on Wednesday, June 17, 2015, at 4:00 P.M, U.S. Eastern Daylight Time (6:00 A.M. Australian Eastern Standard Time on Thursday, June 18, 2015), at the Clarion Hotel & Conference Center located at 148 Sheraton Drive, New Cumberland, Pennsylvania 17070, for the following purposes:
1. For the purposes of the Australian Securities Exchange (“ASX”) Listing Rule 7.4 and for all other purposes, to ratify the issuance and sale by us on February 4, 2015 of 12,650,000 shares of common stock (equivalent to 75,900,000 CHESS Depositary Interests (“CDIs”)) in an underwritten public offering pursuant to a registration statement filed by us with the U.S. Securities and Exchange Commission (“SEC”), and the accompanying prospectus supplement that we filed with the SEC and ASX on January 30, 2015 (“Proposal No. 1”); and
2. To transact such other business as may properly come before the meeting or any adjournment or postponement of the special meeting.
While visiting the FDA site I noticed that the "Endocrinologic and Metabolic Drugs Advisory Committee" had scheduled a June 10 meeting to discuss Praluent. Admittedly, I don't know enough about the FDA's process to know whether this is a preliminary meeting or the meeting that qualifies as the priority review. Anyway, thought I sould share the info.
The announcement can be found on the FDA site, in the 2015 Advisory Committee Calendar. The meeting agenda is as follows:
"The committee will discuss the safety and efficacy of biologics license application 125559, proposed trade name PRALUENT (established name: Alirocumab) for injection, submitted by Sanofi Aventis, U.S., as an adjunct to diet, for long-term treatment of adult patients with primary hypercholesterolemia (non-familial and heterozygous familial) or mixed dyslipidemia including patients with type 2 diabetes mellitus, to reduce low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B, tryglyceride, and lipoprotein A, and to increase high-density lipoprotein cholesterol and apolipoprotein A-1 either in combination with a statin or as monotherapy including in patients who cannot tolerate statins."
The announcement goes on to say "FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting." The FDA webpage provides a link for background materials, once published.
For what it's worth, just read that "an expanded access program has been initiated for the PCSK9 inhibitor alirocumab (proposed brand name Praluent) as it awaits FDA approval."
A representative for drugmakers Sanofi and Regeneron told MedPage Today that access prior to commercial availability would be on the following basis:
"Eligible patients are those who have severe hypercholesterolemia not controlled with a maximum tolerated dose of lipid-lowering therapy, such as a statin, along with diet..."
Source: MedPage Today, 11 May.
Oh, the humanity! Just 12 days ago you self-reported that you were trying to buy at $3.51. Twelve days later you’re complaining that everything Alan has ever said has been a huge exaggeration. Long ago you mentioned that you were one of the largest individual investors in UNIS. If we take that at face value, one would expect an occasional positive comment on the company’s development, but anyone willing to take the time to read your comments would be hard-pressed to find positive references. Same old drumbeat... I was wronged, betrayed, taken in by “huge exaggerations”, a poor victim..... who just 12 days ago was trying to Buy. You’ve even taken to speaking of yourself in third person. Seems you are more interested in creating a cynical, crusty blog persona than actually discussing the company and its prospects and challenges.
I believe your predictable angst is misdirected and your penchant for name calling is regretable. Are you refuting that Pharmas control when they wish to make public public disclosures?
Unilife has announced deals with Sanofi, Astra Zenica/Medimmune, Hikma, Sanofi again, Ocu-ject and are currently negotiating with Abbvie. Obviously it's in their best interest to disclose new agreements as early as possible. What would your advice be? "Work faster?", "Work harder?"or "Screw what the Pharmas want, tell us anyway!"
Alan and Ramin confirm that Unilife has 20 active programs. Many are purportedly major Pharmas with multiple biologics or vaccines. Both Alan and David confirm the R&D spend is directly related to new or current programs, with emphasis on modifications to include bluetooth capabilities (a potentially-lucrative distinction).
Months ago Alan and Ramin suggested they could be cash-positive relatively quickly, but in interest of developing long-term deals, it wouldn't be the wisest course of action. Yesterday there was a shift in tone.
David stated "While there is still hard work and additional investment to come, I believe the key ingredients for success are in place. Moving forward there’s one key metrics that we’ll be using to gauge the future success of our business and that is our ability to generate cash."
"Our goal is to drive Unilife towards self sustainability from a capital perspective and then to continue building our cash and revenue on the back of long-term supply agreements that provide an attractive operating margins." I take that as a positive, given David's credentials.
I think I am as interested as the next person to hear good news, but I'm not looking for a couple of positive announcements to boost the SP a few dollars, then sell. I'm in it for a few years and anticipate a dozen new deals, significant, dependable revenue and the dissipation of shorts... or an outright buyout along the way. I'm in it for $20.00/share.
Itsalongroad75, I also found it interesting that we didn't hear of new customer programs. Alan mentioned the same number as was discussed during the last call.
On a couple of occasions they mentioned how involved it was to put together these programs, from start to fruition. They also stated an intent to focus on large pharmas with multiple biologics.
It wasn't too long ago that a deal announcement, any announcement, was worth the effort, as it added to their credibility. Now, with the deals already signed and 20 more in the wings, they may have determined that chasing every new deal may not be the best use of their resources. Hence, their desire to focus on large pharmas to benefit from established relationships, multiple applications and economies of scale.
Well, let's just say I am happy with the company we keep. Abbvie was even willing to pay 5 mil to have the opportunity to negotiate. Of this I'm pretty certain, a year from now longs will be hear actively discussing the latest positive developments and the effect on the share price, while you will have moved on to a new board, shoveling the same old #$%$ under a newly-created Yahoo name...just like N2B. It's a living I suppose, but no matter how you look at it, it's still shoveling #$%$.