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Biodel Inc. (BIOD)

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Last Post: 10/24/2016 5:16:02 PM - Followers: 86 - Board type: Free - Posts Today: 3

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. 




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Current Price
Bid Ask Day's Range
BIOD News: Additional Proxy Soliciting Materials (definitive) (defa14a) 04:41 PM
BIOD News: Current Report Filing (8-k) 04:38 PM
BIOD News: Biodel Announces Adjournment of Annual Meeting until Thursday, October 27, Urges Stockholders to Vote 04:01 PM
BIOD News: Additional Proxy Soliciting Materials (definitive) (defa14a) 10/19/2016 06:05:35 AM
BIOD News: Current Report Filing (8-k) 10/19/2016 06:05:35 AM
News News Alert: Additional Proxy Soliciting Materials (definitive) (defa14a) 10/24/2016 04:41:45 PM
#2040   I had to own sep 16 or earlier Peabody27 10/24/16 05:16:02 PM
#2039   why not lapared2008 10/24/16 05:08:21 PM
#2038   Man! I can't vote :-( Peabody27 10/24/16 05:06:34 PM
#2037   The merger is on the way, than come kondziu 10/21/16 12:43:32 PM
#2036   Was going to buy,ill wait to see how sick nam vet 10/21/16 10:37:56 AM
#2035   Shareholders meeting,vote on r/s 30 to 1!!! The sick nam vet 10/21/16 10:36:45 AM
#2034   BIOD is a $300MM cap company with the TraderUsa 10/19/16 10:58:44 AM
#2033   Tomorrow or Friday go to $1! Time to time... TraderUsa 10/19/16 10:56:43 AM
#2032   Pre-market ask at $ .71...Geeez ! paulsbest 10/19/16 08:52:20 AM
#2031   FDA vouchers took place for more than $350M paulsbest 10/18/16 01:17:56 PM
#2030   Obviously yes, cause there is heavy weight in paulsbest 10/18/16 01:06:42 PM
#2029   Will biodel stock go up with the merger? Billthegoat 10/17/16 03:48:39 PM
#2028   Wishing well? Who ist first to put new paulsbest 10/13/16 07:02:04 AM
#2027   200 shares: Rymankoly 10/11/16 05:19:54 PM
#2026   Aftermarket boomin Ross92 10/11/16 04:53:41 PM
#2025   BIOD bullish 0.56 stocktrademan 10/07/16 04:52:15 PM
#2024   Wooow Bullenjagd31 10/07/16 03:46:27 PM
#2023   When we will See 1$? Bullenjagd31 10/07/16 01:39:48 AM
#2022   Here’s Why Biodel Just Gained, And What It trendmkr 10/06/16 11:35:51 AM
#2021   <<the drug is called elobixibat, and it is nsomniyak 10/06/16 12:08:42 AM
#2020   Here's Why BIOD is up 25% in the djpope 10/05/16 08:05:26 PM
#2019   Too many catalysts. Go. Biod TOM611 10/05/16 08:44:28 AM
#2018   * * $BIOD Video Chart 10-04-16 * * ClayTrader 10/04/16 05:14:34 PM
#2017   Anyone knows the share structure? There'll be reverse moneytome 10/04/16 12:45:17 PM
#2016 Unilife paulsbest 10/04/16 10:42:44 AM
#2015   Will AstraZeneca take the biodel assets into account paulsbest 10/04/16 10:38:41 AM
#2014   Think ist Couleur Jump in .10 Cents Periodes kondziu 10/03/16 06:00:57 PM
#2013   $BIOD Now @ $.519 +0.053 +11.37% on 83,000 djpope 10/03/16 05:29:32 PM
#2012   I'm awake. Where do u think this is Billthegoat 10/03/16 04:11:49 PM
#2011   Wake up! kondziu 10/03/16 09:06:08 AM
#2010   Biod entered into. Licensing and asset purchase w TOM611 09/10/16 09:43:44 AM
#2009   Woah.. some activity in the aftermarket... Ross92 09/09/16 11:47:01 PM
#2008   Not sure but I think in near future Billthegoat 09/08/16 11:26:49 AM
#2007   That's old news. Do we know where they Ross92 09/08/16 10:54:43 AM
#2006   Very good investment...... That's what I was thinking Billthegoat 09/08/16 07:55:03 AM
#2005   Merger with Albireo! : qu1111 09/08/16 07:52:58 AM
#2004   I'm not sure but I thing they are Billthegoat 09/08/16 06:46:01 AM
#2003   On a side note I do notice a Ross92 09/08/16 01:28:42 AM
#2002   Can anyone tell me or does anyone know Ross92 09/08/16 01:22:53 AM
#2001   Is this a good move? Billthegoat 08/22/16 11:11:48 AM
#2000   BIOD: STEM-clone on merger. Naked shorts in trouble...eom. remind2 08/17/16 09:17:57 AM
#1999   Has symbol change already occurred? nsomniyak 08/17/16 08:13:25 AM
#1998   Biodel Inc.(BIOD) AH Trading $.43990 +.0498 +12.77% djpope 08/16/16 08:46:16 PM
#1997   STEM deal puts BIOD InPlay. New Nasdaq ticker remind2 08/16/16 06:14:23 PM
#1996   BIOD @ .4498 getting serious action now in AHs Ricky-D 08/16/16 06:13:43 PM
#1995   That's old news and any jump in share Samgot7 08/16/16 06:00:42 PM
#1994 MarketWiz152 08/16/16 05:12:52 PM
#1993   Got a link to that "PENDING MERGER" you NotRichYet2 08/16/16 05:02:45 PM
#1992   BIOD: Pending merger sets up a STEM-like move. remind2 08/16/16 04:36:38 PM
#1991   BIOD WOW 60,000 @ 0,4099 Ricky-D 08/04/16 12:34:50 PM