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ALBO on TD Ameritrade.
They have a couple phase 2 drugs and one phase 3 drug.They have money and can raise money with forward splits which we can benefit from,with such a tiny share structure there are many ways to benefit.Its the Nasdaq so its not like penny stocks.I think this is a winner.I think we might be the only ones here.I guess there's a couple more people here,this may be flying under the radar.Maybe we're in on the ground floor.GLTU.Go ALBO
Yes it looks like they do have some promising things in the works I think the European folks might push it along
That's a better guess than mine but I'm hopeful.It seems like Albireo has alot going on and people will do some dd and maybe buying will create a frenzy.
Around 18 to 20. Hope it's 50 lol. There is going to be. A 30-1 split isn't there
Whats your guess?
My guess is $22.00 with 10,000,000 shares outstanding.Go ALBO
What will ALBO open at tomorrow ? Any guesses
Biodel / Albireo Reverse Merger Complete! New Symbol ALBO
Albireo Completes Transaction with Biodel to Create Publicly Traded Company Focused on Orphan Pediatric Liver Diseases
GlobeNewswire•November 3, 2016
https://finance.yahoo.com/news/albireo-completes-transaction-biodel-create-153000218.html
— Albireo Pharma, Inc. to trade on The NASDAQ Capital Market under symbol “ALBO” —
— Company to develop novel bile acid modulators to treat orphan pediatric liver diseases, other liver and gastrointestinal diseases —
BOSTON, Nov. 03, 2016 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc., a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators through its operating subsidiary, today announced the completion of the share exchange transaction between Biodel Inc. (BIOD) (through November 3) and Albireo Limited and its shareholders and noteholders, effective as of November 3, 2016. The combined organization will be called Albireo Pharma, Inc. and will commence trading on The NASDAQ Capital Market on November 4, 2016 under the symbol “ALBO.”
Completion of the share exchange, together with $10 million in new capital invested prior to the closing by existing Albireo Limited investors, provides approximately $30 million to enable Albireo to advance development of its pipeline, including its lead product candidate, A4250, in development for the treatment of progressive familial intrahepatic cholestasis (PFIC). PFIC is a life-threatening orphan liver disease that affects young children.
“The completion of the share exchange is an exciting step in the evolution of Albireo as we enter the public markets with funding expected to be sufficient to progress A4250 into a planned pivotal trial in PFIC, which we anticipate starting next year,” said Ron Cooper, President and Chief Executive Officer of Albireo. “We believe A4250 has the potential to become a much needed, nonsurgical treatment option for children suffering from PFIC or other rare cholestatic liver diseases.”
On November 3, 2016, prior to the closing of the share exchange, Biodel completed a one-for-thirty reverse stock split. As a result of the reverse stock split, every 30 shares of Biodel common stock outstanding immediately prior to the share exchange was combined and reclassified into one share of Biodel common stock. No fractional shares are being issued in connection with the reverse stock split. Instead of fractional shares, cash will be issued based on the closing price of Biodel common stock on The NASDAQ Capital Market on November 2, 2016.
The holders of ordinary shares of Albireo Limited immediately prior to the share exchange received 0.06999 shares of Biodel common stock in exchange for each ordinary share. This exchange ratio reflects the reverse stock split. Following the reverse stock split and the share exchange, Albireo has approximately 6,294,725 shares outstanding.
The combined organization will operate under the leadership of Albireo’s officers, including: Ron Cooper, President and Chief Executive Officer; Jan Mattsson, Chief Operating Officer; Tom Shea, Chief Financial Officer and Treasurer; Paresh Soni, Chief Scientific Officer; and Pete Zorn, Senior Vice President, Corporate Development and General Counsel. The board of directors of the combined organization is comprised of seven members, including five directors from Albireo Limited’s former board, David Chiswell, Ph.D., Michael Gutch, Ph.D., Heather Preston, M.D., Denise Scots-Knight, Ph.D., and Mr. Cooper, and two directors from the former Biodel board, Julia R. Brown and Davey S. Scoon. Dr. Chiswell is the new Chairman of the Board. The combined organization’s corporate headquarters are in Boston, Massachusetts.
About Albireo
Albireo is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo’s clinical pipeline includes two Phase 2 product candidates and one Phase 3 product candidate. Albireo traces its origins to a spinout from AstraZeneca in 2008.
Albireo is located in Boston and its wholly owned direct and indirect subsidiaries are located in London and Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.
I guess the annual meeting is on for tomorrow and we must have gotten enough votes to move forward with the merger otherwise they would have put out a pr.
Biod? Go go go. Do not care trump and clintonian.
Three Big Biotech Movers: Insider Monkey
http://www.insidermonkey.com/blog/here-are-three-big-biotech-movers-and-our-take-on-whats-next-483757/
Here Are Three Big Biotech Movers And Our Take On What’s Next
Published on October 28, 2016 at 11:20 am by Market Exclusive in Market Movers,News,Stock Analysis
Finally, Biodel Inc (NASDAQ:BIOD).
This one isn’t as straightforward. To simplify the situation, Biodel is looking to merge with a private company called Albireo. The two are hoping to combine in what is essentially a reverse merger for Albireo using Biodel as a vehicle through which to gain a quick NASDAQ listing. If it is succesfull, the combined entity will focus on diseases of the liver, and attempt to push forward a pipeline that comprises primarily Albireo’s assets.
However, in order for the deal to go through, Biodel needs to persuade its shareholders that it is in their interests, and these shareholders need to vote by way of a proxy to approve the merger. The company set up an annual meeting at which it had hoped to gain enough votes to push the merger though, but by the proposed date, it was unable to secure said requirement.
As such, the meeting has now been delayed and pushed back to November 3. Between now and then, Biodel will be contacting investors essentially begging them for their vote. The company is down from a market cap perspective, based on this fact.
We think, however, that the vote will eventually go through, as while it’s not a great exit for investors, it’s better for them than Biodel Inc (NASDAQ:BIOD) pushing forward alone with a diminished pipeline.
Buyout for Biodel. Astra is coming! A great dip. And this was the last chance.
read the last PR where they talk about ENDING ( dissolving = selling off ) the company
BUT , in case they DO get enough votes ,
then it's 1 for 30 R/S = PPS $ 15
__________________________________________________________
then read the LAST paragraph here :
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=125608337
................ NOW you know ............
GLTA
Annual Meeting Adjourned (again) until Thursday, November 3
Guess nervous nellies, short term flippers and capital preservationists are bailing. I'm in with a .27 average and will continue to hold till the outcome. No sense in bailing now with the potential merger and possible share price increase so close. To me; It's worth the risk. Gotta be in it to win it.
For the size of the drop the volume isn't that unusually heavy and level II shows more bids than asks.
Best to all dp
http://finance.yahoo.com/news/biodel-announces-intent-further-adjourn-231800003.html
Biodel Announces Intent to Further Adjourn Annual Meeting until Thursday, November 3
[PR Newswire]
October 26, 2016
DANBURY, Conn., Oct. 26, 2016 /PRNewswire/ -- Biodel Inc. (BIOD) ("Biodel") announced today that, assuming it has not received from stockholders sufficient proxies to approve the matters necessary to complete its proposed combination with Albireo Limited pursuant to a previously announced share exchange agreement prior to 8:30 a.m. local time on Thursday, October 27, 2016, it intends to again adjourn its 2016 Annual Meeting of Stockholders ("Annual Meeting"), now scheduled for October 27, 2016, without any business being conducted. In that circumstance, Biodel intends to adjourn the Annual Meeting to 8:30 a.m. local time on Thursday, November 3, 2016, at the offices of Wiggin and Dana LLP, Two Stamford Plaza, 281 Tresser Boulevard, Stamford, Connecticut 06901 (the "Further Adjournment").
Biodel notes the following important considerations.
The Further Adjournment would be intended to allow additional time for stockholders to vote on the proposals set forth in Biodel's definitive proxy statement for the Annual Meeting, filed with the Securities and Exchange Commission on September 19, 2016. As of October 26, 2016, proxies have been submitted by stockholders representing approximately 49.83% of the outstanding shares of Biodel common stock outstanding and entitled to vote at the Annual Meeting, meaning that almost 32.2 million shares remain unvoted.
In particular, the Further Adjournment would be intended to allow additional time for Biodel's stockholders located in Germany and elsewhere in Europe to contact their banks and brokers to request proxy materials and to provide voting instructions to those banks and brokers. There is a significant number of shares that Biodel understands to be held by stockholders in Europe that have not yet been voted.
Biodel reminds all of its stockholders, even those who may have already voted, that the proposed combination with Albireo cannot be completed without approval of both "Proposal No. 1" (share issuance) and "Proposal No. 2" (reverse stock split), each as described further below. Of the proxies received as of October 26, 2016, approximately 94.13% are in favor of Proposal No. 1, and approximately 88.67% are in favor of Proposal No. 2, reflecting widespread support for the combination.
If the proposed combination with Albireo does not close, the Biodel board of directors may decide to sell or otherwise liquidate the various assets of Biodel. If Biodel decides to dissolve and liquidate its assets, there can be no assurances as to the amount or timing of any available cash that may be left to distribute to stockholders after paying the debts and other obligations of Biodel and setting aside funds for reserves. This would also result in the loss of significant effort and expense incurred to date in pursuing the proposed combination with Albireo.
If the Further Adjournment is implemented as intended, Biodel does not anticipate making a further announcement as to the adjournment.
YOUR PARTICIPATION IS IMPORTANT - PLEASE VOTE TODAY!
Please call Morrow Sodali at (800) 662-5200 or +44 (0)20 71006451 for voting assistance.
The Annual Meeting has been called for the following purposes: (1) to consider and vote upon a proposal to approve the issuance of shares of Biodel common stock pursuant to the Amended and Restated Share Exchange Agreement, dated as of July 13, 2016, by and among Biodel, Albireo and Albireo securityholders ("Proposal No. 1"), (2) to effect a reverse stock split of Biodel common stock in the ratio of one new share for every 30 shares outstanding ("Proposal No. 2"), (3) to approve a new equity incentive plan for use by Albireo Pharma, Inc. from and after the closing of the proposed transaction, (4) to elect two Class III directors for a term of three years and (5) to consider and vote upon an adjournment of the Annual Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of any of Proposals No. 1-4.
The record date for the Annual Meeting remains September 16, 2016. Biodel stockholders as of the September 16, 2016 record date can vote, even if they have subsequently sold their shares. Biodel's board of directors and management respectfully request all such holders as of the record date to please vote your proxies as soon as possible.
No changes have been made in the proposals to be voted on by stockholders at the Annual Meeting. BIODEL STRONGLY ADVISES ALL OF ITS STOCKHOLDERS TO READ THE PROXY STATEMENT AND OTHER PROXY MATERIALS RELATING TO THE ANNUAL MEETING BECAUSE THEY CONTAIN IMPORTANT INFORMATION. SUCH PROXY MATERIALS ARE AVAILABLE AT NO CHARGE ON THE SECURITIES AND EXCHANGE COMMISSION'S WEBSITE AT WWW.SEC.GOV. In addition, copies of the Proxy Statement and other documents may be obtained free of charge by accessing Biodel's website at www.biodel.com or by contacting Biodel's Corporate Secretary at 203-796-5000 or by mail at Investor Relations, Biodel Inc., 100 Saw Mill Road, Danbury, Connecticut 06810. If the number of additional shares voted is not sufficient to approve the proposals, Biodel intends to adjourn the Annual Meeting again, which may be costly.
Voting Instructions
All stockholders as of the September 16, 2016 record date can vote, even if they have subsequently sold their shares, and Biodel encourages stockholders to do so before November 2, 2016 at 11:59 p.m. Eastern Time. Stockholders are reminded that their vote is extremely important and are urged to complete, sign, date and mail the proxy card at their earliest convenience. Stockholders may also submit a proxy by telephone or via the Internet by following the instructions printed on the proxy card.
About Biodel
Biodel Inc. is a specialty biopharmaceutical company. More information about Biodel is available at www.biodel.com.
Additional Information and Where You Can Find It
Biodel filed a definitive proxy statement with the SEC on September 19, 2016 in connection with the solicitation of proxies for its 2016 Annual Meeting of Stockholders and has mailed the definitive proxy statement and other relevant materials to Biodel's stockholders. At the 2016 Annual Meeting of Stockholders, Biodel's stockholders will be asked to approve, among other things, a proposal for the issuance of Biodel's common stock in the previously announced proposed transaction with Albireo. BIODEL'S STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN CONNECTION WITH THE SOLICITATION OF PROXIES FOR BIODEL'S 2016 ANNUAL MEETING OF STOCKHOLDERS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT BIODEL, ALBIREO AND THE PROPOSED TRANSACTION. These documents and other documents filed by Biodel can be obtained free of charge from the SEC's website at www.sec.gov. These documents also can be obtained free of charge by accessing Biodel's website at www.biodel.com or by contacting Biodel's Corporate Secretary at 203-796-5000 or by mail at Investor Relations, Biodel Inc., 100 Saw Mill Road, Danbury, Connecticut 06810.
Participants in Solicitation
Biodel, Albireo, their respective directors and executive officers and other persons may be deemed to be participants in the solicitation of proxies from Biodel's stockholders in connection with Biodel's 2016 Annual Meeting of Stockholders under the rules of the SEC. Information about these participants, and a description of their direct and indirect interests, by security holdings or otherwise, may be found in the definitive proxy statement that Biodel filed with the SEC on September 19, 2016 relating to its 2016 Annual Meeting of Stockholders. The definitive proxy statement was mailed to all stockholders of record as of the record date set for the 2016 Annual Meeting of Stockholders and can also be obtained free of charge from the sources indicated above. Other information regarding participants in the proxy solicitation may be contained in other relevant materials filed by Biodel with the SEC.
Nice dj, every little bit helps thanks
After a round-a-bout circle jerk I was finally able to vote for the BIOD/ALBO merger tonight. I ended up getting the Control # needed to vote from my Broker (e-trade) after they sent me on a wild goose chase yesterday that eventually brought me back to them with a (better) customer service representative than the one that sent me away chasing rainbows yesterday.
Got the Control # and voted with no problem at
https://central.proxyvote.com/pv/web
Best to all dp
I never got (or misplaced??) the Proxy Statement so I called etrade trying to get it done.
They said to go to Biodel Investor Relations to get a Control # @
http://investor.biodel.com/
and then use that to place Vote @
https://central.proxyvote.com/pv/web
Just sent Biodel IR Contact a question asking for this number using the link above.
Will update board if I make any progress or get a reply.
"Better late then never"... Seems to apply here. When I couldn't find it I just said well it's only 10,000 shares and shouldn't make any difference but it seems like they want (or need?) every vote they can get so like they say:
> Get out and Vote if you already haven't <
Out of curiosity - Anyone else "missing" their proxy mailing??
Best to all dp
I had to own sep 16 or earlier
The merger is on the way, than come the big player and buy it out. Now You get the shares for a peanut. Assets of Biodel more than 50 million worth. Albo Pipeline 1,5 more than billion worth. Good luck guys who want jump on later.
Was going to buy,ill wait to see how the vote goes.
Shareholders meeting,vote on r/s 30 to 1!!! The Definitive Proxy Statement on Schedule 14A of Biodel Inc. (“Biodel” or “Company”), filed with the Securities and Exchange Commission (the “SEC”) on September 19, 2016 (the “Proxy Statement”) stated that brokers were not expected to have discretionary authority to vote for any of the proposals to be voted on at the Company’s 2016 Annual Meeting of Stockholders to be held on October 24, 2016. The Company has since determined that brokers have discretionary authority to vote for (i) Proposal No. 2 , the proposal to approve an amendment to the Company’s amended and restated certificate of incorporation to effect a reverse stock split of the Company’s common stock in the ratio of one new share for every 30 shares outstanding and (ii) Proposal No. 5 , the proposal to consider and vote upon an adjournment of the Company’s 2016 Annual Meeting of Stockholders, if necessary, to solicit additional proxies if there are not sufficient votes in favor of any of Proposal Nos. 1 through 4 to be voted on the Company’s 2016 Annual Meeting of Stockholders. Therefore, the Company hereby amends the Proxy Statement to clarify that each of Proposal No. 2 and Proposal No. 5 is a “routine” matter and that, as such, a broker will have discretion to vote on Proposal No. 2 and on Proposal No. 5 even if the broker has received no voting instructions from its clients with respect to such proposal.
BIOD is a $300MM cap company with the new trials with Albireo...
Tomorrow or Friday go to $1! Time to time...
Pre-market ask at $ .71...Geeez !
Vote for a ALBO room temperature stable inhibitor at A4250 and NASH in crystal modification processes ? Then vote for BIOD ! They've done it already at glucagon.
Patent
$$$ GLTA $$$
FDA vouchers took place for more than $350M in exchange, so put it on those roundabout 7M ALBO shares and cut it off for r/s (30:1).
Like this: 350M ./. 7M ./. 30 = $1,66 for each share. And another for NASH. Geeeez. Thats why they are loading...IMO
'Nobody knows the trouble I see...$$$'...GLTA $$$
Obviously yes, cause there is heavy weight in assets ahead.
Can't be compared with those snuff board companies, who are painting the tape every single minute.
Loading BIOD...§§§ GLTA §§§
Will biodel stock go up with the merger?
Wishing well? Who ist first to put new Albireo on his shopping list ?
NEW Proxy update
This will drop into many hands. Be the first? Geeez.
merge/split/fda/m&a...easy. $$$ GLTA $$$
Aftermarket boomin
Here’s Why Biodel Just Gained, And What It Means
http://marketexclusive.com/heres-biodel-inc-nasdaqbiod-just-gained-means/33155/?icd1
<<the drug is called elobixibat, and it is targeting chronic constipation>>
Damn! This is huge!
Alberio has a cure for ... being full of shit. :)
Perhaps they will give free samples to iHub posters, many of whom could use a dose...
Here's Why BIOD is up 25% in the last 2 days...
And is up 143% from a low close for the year of (0.24 in January) to today's close at (0.585)
Actually, the attached article isn't the whole story but it sure seems enough of a reason to raise a lot of interest... and BIOD share price too.
Some additional reasons Why? BIOD is surging ahead is that it recently won a judgement against UNIS (Unilife Corporation) for "Failure to Deliver" on a pivotal clinical trial contract along with the fact that the BIOD pipeline will be sold prior to the ALBO reverse merger as it doesn't fit into the New companies area of interest and the proceeds will be distributed to existing BIOD shareholders.
Quite a trifecta for continued share price appreciation as I see it.
Best to All and Enjoy! dp
http://www.insidermonkey.com/blog/heres-why-biodel-inc-biod-just-gained-and-what-it-means-478828/
Here’s Why Biodel Inc (BIOD) Just Gained, And What It Means
A small cap biotech named Biodel Inc (NASDAQ:BIOD) based out of Connecticut just logged close to 20% gains yesterday. At first glance, there’s very little to support the move. Dig a bit deeper, however, and things become clear. The company is set to merge with a Japanese company called Albireo Limited near term, and once the merger completes, the two will trade under BIOD (at least, initially, then change it to ALBO) but Albireo’s name.
The operations of the new entity will continue as the shared operations of the two legacy companies, so it stands to reason that some positive news for Albireo would – by proxy – be positive for Biodel Inc (NASDAQ:BIOD).
So, it’s something related to Albireo that drove the action – right?
That’s right.
The company just announced that it had met the primary endpoint from a phase III clinical trial of its lead chronic constipation candidate, elobixibat – a trial conducted in the company’s native Japan. If the drug can pick up an FDA approval, and we’re pretty certain this is the motive behind the merger – in essence, it’s basically a reverse merger to avoid a NASDAQ IPO – then there’s a potentially large upside for the newly formed entity.
With this in mind, let’s have a look at the drug in question, and attempt to put a value on an approval.
As mentioned, the drug is called elobixibat, and it is targeting chronic constipation. It is part of a family of drugs called selective IBAT inhibitors, and it is essentially an attempt to leapfrog the current standard of care treatments in the space by reducing the side effects associated with treatment. How does it do this? Well, the majority of the current SOCs are systematic, and perform their primary function in the small intestine. In contrast, elobixibat operates locally in the colon. Its primary mechanism of action is to block reabsorption of bile acids from the small intestine into the liver, and by doing so, increase secretion and motility, countering the negative symptoms of this chronic condition.
The phase III in question was targeting a primary endpoint of a change in the number of weekly spontaneous bowel movements (SBMs), specifically, a marked increase, from baseline to the first treatment week compared with placebo.
The trial hit this endpoint with a high degree of statistical significance, while also hitting on a number of secondary endpoints – change in frequency of complete SBMs, time to first SBM, severity of constipation and stool consistency, and a few more – and maintaining a low degree of intolerability.
The only real adverse events were mild, and pretty much fell in line with expectations – a few patients with diarrhea, some abdominal pain, that sort of thing. Nothing severe, and not in more than around 13% of patients.
So what’s next?
Well, we expect the company to wait until it closes on the merger before acting on the data with the FDA and submitting a registration application. As such, we are looking to this merger as the next major catalyst. Once that completes, which the two companies expect it will before the close of the fourth quarter, we will look for an NDA submission, and subsequent acceptance, by the agency, as a secondary revenue driver.
Beyond that, of course, it’s all about PDUFA.
So, to go back to our initial question, what are the chances of approval, and what is the size of the market on an FDA green light?
We think the chances of approval are high based on the latest data, and that the company should have no problem getting an authorization approved. Of course, this is subject to the standard levels of uncertainty at this end of the biotech space, but right now we don’t see anything that is hindering its chances. From a market perspective, the CIC space was worth a little over $I.6 billion last year, and is expected to hit $2.5 billion by 2022.
The primary risk here is capital. Neither company has too much cash on hand, and a CIC push is going to require a high degree of initial marketing capital. This points to a near-term raise, which in turn, points to some dilution at some point during early next year. If the company can execute a marketing strategy successfully, there’s no reason why this raise (and dilution) can’t be mitigated, but it has to be consideration for an early-stage investor.
Note: This article is written by Mark Collins and was originally published at Market Exclusive.
Too many catalysts. Go. Biod
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http://finance.yahoo.com/q/ks?s=BIOD
Biodel, Inc., a development stage specialty pharmaceutical company, focuses on the development and commercialization of treatments for endocrine disorders, such as diabetes and osteoporosis in the United States. The company develops its product candidates by utilizing its proprietary VIAdel technology. It has two insulin product candidates in clinical trials for the treatment of diabetes, including VIAject and VIAtab. VIAject is an injectable formulation of recombinant human insulin, which is in pivotal Phase III clinical trials in patients with Type 1 and Type 2 diabetes. VIAtab is a sublingual tablet formulation of insulin, which is in Phase I clinical trial in patients with Type 1 diabetes. Biodel also has two preclinical product candidates for the treatment of osteoporosis comprising VIAmass, a sublingual formulation of parathyroid hormone 1-34; and VIAcal, a sublingual formulation of salmon calcitonin. The company was founded in 2003 and is based in Danbury, Connecticut.
3/15/2011 March 14, 2011, Biodel Inc. Announces Accelerated Development Plan for Ultra-Rapid-Acting Insulins
Biodel Inc. announced that it has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates. The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins. Biodel plans to test these formulations in a Phase 1 clinical trial of approximately 18 patients with Type 1 diabetes. This study is designed as a double blinded, three-period cross over trial in which patients will receive one subcutaneous injection of BIOD-105, BIOD-107 and Humalog(R) each on separate occasions. This study, expected to be completed in the third calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and tolerability profiles of the two experimental insulins relative to that of Humalog(R). In parallel with this subcutaneous injection study, Biodel plans to utilize a similar design to conduct a clinical pump study this year. If this Phase 1 study is successful, Biodel now anticipates initiating a Phase 2 study in patients with Type 1 diabetes in the fourth calendar quarter of 2011. The Phase 2 study is intended to follow the same overall design that would be implemented in Phase 3 studies, which would include two separate pivotal trials-- one in patients with Type 1 diabetes, and the other in patients with Type 2 diabetes. Biodel recently received initial guidance from the U.S. Food and Drug Administration (FDA) on the design of two pivotal Phase 3 clinical trials. Based on this guidance, Biodel plans to design the Phase 2 and 3 studies as randomized parallel group studies using Humalog(R) as a comparator in which active dose titration will occur in the first two months after randomization followed by three months of relatively stable dosing. In these studies, Biodel plans to evaluate efficacy using HbA1c as well as measures of postprandial glucose profiles. If the results of the Phase 2 testing are successful, the company plans to launch Phase 3 pivotal studies required for approval in 2012 rather than its previous guidance of 2013.
Coverage:
http://finance.yahoo.com/q/ud?s=BIOD
Blogs:
http://seekingalpha.com/article/227766-biodel-upside-from-potential-linjeta-approval?source=yahoo
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