anyone understands the impact of GDUFA on taro. I guess GDUFA filings are getting approved in shorter timeline.
1) expect more competition on some of taro's products
2) Assuming taro has filed some of its products under gdufa, expect shorter timeline and accelerated launches.
Am i right in these conclusions. Any thoughts appreciated.
The FDA has approved Teligent Inc’s abbreviated new drug application for desoximetasone ointment USP 0.25%, which is the generic equivalent of Taro Pharmaceuticals’ Topicort Ointment.
The market for this topical product, which is used to treat swelling and itching caused by skin disorders, is around $17 million, according to IMS Health data from December 2015.
Teligent submitted the abbreviated new drug application to the FDA back in November 2014.
"Teligent received FDA approval for desoximetasone ointment USP 0.25% in 15 months in a first cycle review, which is consistent with the FDA's goals under the Generic Drug User Fee Amendments (GDUFA),” said Jason Grenfell-Gardner, president and CEO of Teligent, in a press release. “This is our first product approved from our pipeline of applications filed under GDUFA Year 3, which began on October 1, 2014.”'
Teligent said it hopes to launch the ointment in 15 g, 60 g, and 100 g tubes in the second quarter of 2016.
I guess he is demanding response by March 10th. Anyone knows he got any response from board?
I am surprised the prospects of more disclosure and the win in delaware has not moved the stock much. I would have thought it would easily be over $4....but still trading at $1.7
valery - didn't know are you in MNTA? MNTA has always been "good tech, bad stock" as far as I am concerned. Sold it long time back after a 20 percent haircut.
at $41-$42 per share.
You still have to ask why ?
Did he need 36m USD to buy expensive beach home, yachts,etc ?
Why didn't he think being invested in the business he is running is a better long term investment ?
Why was he so easily willing to sell his stake in the business for some cash?
I like insider ownership
Personally I don't like CEO's who cash out on shares beyond what they need for their living.
FDA inspection of Indian plant is a risk considering so many indian plants struggle to comply with FDA;s stringent quality guidelines.
Besides why is there insider sales ? In reading through brief history and how it is performing , i dont like this management .
Who thinks these Kamedis prods n its Open label study is of any significance?
nc., a global provider of clinically proven skin care products, announced today positive results from a clinical study evaluating the safety and efficacy of the Kamedis Bio-Herbal Dandruff Care system in patients with seborrheic dermatitis and moderate to severe dandruff.
In the study, participants experienced an 87 percent improvement in erythema (redness and lesions caused by inflammation) after two weeks of use and 65 percent saw an improvement in the total severity score targeting all symptoms associated with seborrheic dermatitis and dandruff at six weeks. In comparison to other products on the market, participants expressed a 90 percent overall satisfaction rate.
"Many patients with dandruff are unsatisfied with current treatment options, which can be harsh on their hair and may contain sodium lauryl sulfates, parabens or other chemicals that people are moving away from. These results help us better understand the clinical efficacy of Botaniplex, the proprietary combination of botanical concentrates and active ingredients at the core of our evolving line of dermatology products," said Roni Kramer, Chairperson and Chief Executive Officer of Kamedis Inc. "We thank the dermatologists and participants involved with this study, and are pleased the results validate a holistic approach to treatment with a system that is also gentle on the hair and scalp, even for patients with more severe forms of seborrheic dermatitis and dandruff."
The interventional, open-label study, evaluated 50 adult patients with moderate (n=35) or severe (n=15) seborrheic dermatitis or dandruff at baseline and at two, four and six weeks post-use of the system's scalp lotion and shampoo. The primary outcome measures were erythema, loose flaking, Adherent Scalp Flaking Score (ASFS) and results from a patient satisfaction questionnaire. Standardized digital photographs of each participant's scalp were captured at e
Forward P/E (fye Mar 31, 2017)1: 10.05
PEG Ratio (5 yr expected)1: 0.77
Enterprise Value/EBITDA (ttm)6: 8.07
$1.18 billion cash and Zero Debt
Look at the financials in the last 5 years. Flawless....yet it doesn't get iota of credit in the market.
Find me another stock like this.
Thanks for posting. Great letter to see. Shareholders fighting against board breaches is what we desperately need across many many boards today
Wow u are early to work today. Yes ex-shareholder here.
I lost huge after listening at least a dozen calls from 2010, 2011 & 2012.
Little did I doubt someone's integrity. I guess big lesson learnt.
What do you say cavejoesherrybaseballgfys
I also suspected (have no evidence though) that it looked like a scheme going by the relentless short selling happening in Aug 2012 when I purchased n sudden shock & awe way the PR of fusilev downward revision was provided. An after market 8k. If they had any integrity whatsoever they wd have conducted 3 hour conf call same day n explain to shareholders why they were horribly wrong(euphemism) so many times on fusilev (other prods too) forecast....so say off. Meanwhile shorts made $80-$100m? Share price went from $12.5 to $7-$7.5
I would say give it to shareholders like me. #fusilevpump
Shareholders were his counterparty when he sold shares at peak $12.5 (w fusilev growth guidance) n sudden shocker when it was changed to degrowth of ,40% in less than a few weeks.
What do you say cavejoesherrybaseballgfys et al ?
EBITDA is just $208m...they have 100's of niche generic prods....seems like they have not managed the business well.
AKRX - Strong on Injectables, OTC, Nasal Sprays, Respiratory, Opthalmics, Patches and Animal health. Could be complimentary to taro
78 pending filings with 13 para4
every year they are targeting 30-40 ANDA filings
have branded and OTC assets too
Huge and diverse pipeline , mostly partnered with global pharma but can get mid-teen royalties on most products.