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Jeff
I think I remember that this news did not raise the pps. Do you remember that?
Once the FDA denied Libigel because of efficacy, no one cared about safety. Big cv story for those who were reading between the lines.
Thanks Jeff!
Jeff
All the best to you too!
If you run across the 2015 cancer vaccine article again, please post. You have always said that GVAX was our top asset and it seems to be happening!
I agree about luck. It's easy to pat yourself on the back...
JTFM
Good Malibu analogy.
Jeff and Catty were commenting on what made them take the leap to cost average down on BPAX. Aside from being a novice, sheer luck, and the superstar cast of characters as BPAX's directors, for me, this article from 2010 resonated:
http://www.thestreet.mobi/story/10681725/2/biosante-pharmaceuticals-rated-among-top-15-companies-on-the-biotechnology-patent-scorecard8482-as-published-in-the-wall-street-journal.html
That is why these companies don't skimp on intellectual property attorneys.I agree that the value and terms of securing this patent have been established for a while.
JTFM
Nice post on yahoo mb.
Good explantion of how Abbvie (your hunch all along) probably holds the missing piece to the LibiGel puzzle.
Must have been taped a while ago; $30 share price? Even still, Barrons is followed widely.
Thanks, JTFM.
Congratulation everyone on ANIP's outstanding 2014 performance.
Wishing all board regulars and ANI management and staff a healthy and prosperous new year!
That IS a great find. Would love to know more!
Jeff (and JTFM)
It's especially ridiculous when the "drug" is not a foreign substance but instead a naturally occurring essential hormone with demonstrated importance for healthy physiologic functioning!
I don't know much about patents. I do know that T (itself)cannot be patented because it is not an invention. It is a naturally occurring hormone. The patents are all about methodology, dosage, intent, application gizmos, etc., right?
If we had rec'd approval in 2011 because of proven efficacy, could P&G (Intrinsa) have then asked for reconsideration based upon our proven safety? I have wondered about this.Especially because of their Goliath marketing capability.
JTFM
So much time, so many off-label scripts, so many hours in our safety study, so little attention given to women's sexual health...
Hopefully these factors will somehow be used to distinguish us from Dudley.
Thank you again for all that you research and report on our "needle in the haystack!"
Hi Jeff
Are you implying that the Libigel SPA was intentionally flawed to buy time for the patent? Ha. Wouldn't it be great to be able to read actual correspondence between companies and the FDA?
I agree that GVAX is amazing and it's miraculous research and medicine to save lives!
JTFM
Does it matter that the dosages are different? .75 g Dudley .3 g Libigel .5 g research published in Menopause.
http://journals.lww.com/menopausejournal/Citation/2015/01000/Early_menopause_and_subsequent_cardiovascular.1.aspx
This is the lead article in January Menopause. It links early menopause with cv disease! The other article that you referenced in summer on pharmokinetics of transdermal T is there too. I haven't read the entire article because I'm too cheap to log in and pay. Next week it should be available.
http://www.consumerjusticefoundation.com/news/viagra-skin-cancer-suit/
I think the outcome of the viagra/melanoma lawsuits will affect Vitaros sales and APRI pps. JMO.
That's too bad.
I am very curious to read the January issue of Menopause that has been alluded to for several months. Certainly there will be mention of cv benefit:http://www.menopause.org/docs/default-source/2014/testosterone-study-final.pdf
I asked if it was part of programming to allow for CVR's in the event that they are ever issued and he said no, specifically dividends.
He hasn't called back but it was weird that he brought it up because of something he was seeing from his end. Oh well, no complaints. What a great investment!
I just called etrade to speak to customer service about my account (another matter) and the rep asked me if I wanted to set up dividend re-investment with ANIP.
I told him that ANIP has not paid a dividend. He was surprised and said he "would look into it".
Is ANIP planning to pay a dividend?
One type of vancocin that we have in our pipeline is injectable. Antares has an agreement with an undisclosed company for development of an undisclosed injectable med. The following patent was announced a year ago:http://www.marketwatch.com/story/antares-pharmar-announces-notice-of-allowance-for-new-patent-on-reconstitutable-lyophilized-injectables-2013-12-20
Vancomycin is a reconstitutable lyophilized injectable.Vancomycin has a huge market. MRSA and otherinfectious diseases.
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=73ce6c76-7636-49e3-a912-02d56353e009
Another possibility.
http://www.bizjournals.com/prnewswire/press_releases/2014/12/02/SF80018?r=full&full=true
Is this GVAX? Anybody know? Thanks. J
Glad to hear you're still in.Congrats!
That's quite a resume.
I guess we'll just wait to see if the patent is granted.Fingers crossed.
That's quite a resume.
I guess we'll just wait to see if the patent is granted.Fingers crossed.
JTFM
That article was from January 2012, shortly after the efficacy bad news. Maybe the new testing equipment was needed? It would seem that after that research was published, cardiologists would have prescribed T for at least hysterectomied women at risk but I don't think that has happened.
There is a lot of info in that presentation. Thanks for posting it again. Not deleted either!
I wish I had time to really dig into RESX although BPAX to ANIP may be his masterpiece.
Even Fox News acknowledges a connection between T and sex drive for women. This must be heating up!
http://www.foxnews.com/health/2014/11/21/testosterone-has-subtle-influence-on-menopausal-womens-sexual-function-study/
I looked at the JNJ site and didn't see news about Aduro.
Something to watch for.
Antares has an injector under development for testosterone. Their 3Q filing showed payment from an undisclosed company for development of an undisclosed injectable drug.
Could it be T for women? Could the partner be ANI?
I am terrible at the details of patents but look at 28. How could 5mg
of T be significant for a man?
http://www.faqs.org/patents/app/20130303985
Wow. That makes sense. Thanks for posting.
Thanks. Fine with me. Fewer shares react strongly with positive news.
Yippee.
Hi Jeff
You are much more business-savy than I am.
If a company has done a reverse split in the past and they become successful, are they more inclined by do a stock split?
Thanks. Isn't this amazing!
J
http://mobile.nytimes.com/2014/09/14/opinion/sunday/should-we-all-take-a-bit-of-lithium.html?_r=0&referrer=
Slightly off topic but an interesting read. Considering that Lithobid is one of our major revenue producers I thought I'd share this. Did you know that the original 7up contained lithium? I didn't.
Great day. Congratulations everybody. Thank you JTFM for your generosity.
Eicoman,
I agree..
Hopefully, the FDA will be influenced by the sentiment at the recent workshop.
Two rejected drugs:
1. Intrinsa P&G
2. Libigel Biosante pharma
Great post. Thanks.
It made me think of Intrinsa's rejection before Libigel... If Libigel had been approved and efficacy and safety were proven for 300 mcg T, then P&G could have come back with Intrinsa and filed an ANDA, right? and piggybacked on our safety.
They were just 300 mcg T with some goo on a patch.What am I missing?
Maybe Simes knew that? So many mysteries...I think Antares has some big plan brewing: Hobbs is the new board member turned CEO. They just lost their very capable sales director to same company as old CEO. I don't follow Abbvie except for what you post and there are clear links.
I am very interested in news that comes from the October 27th FDA conference. Take care JTFM and thanks for keeping the board alive!
This is the one that I signed:
https://www.yourvoiceyourwish.com/
http://www.prnewswire.com/news-releases/even-the-score-coalition-releases-video-parody-of-viagra-spot-highlighting-absurdity-of-continued-gender-inequity-in-sexual-health-279470512.html
Anyone remember Libigel? Check out upcoming conference and great video.
http://www.prnewswire.com/news-releases/even-the-score-coalition-releases-video-parody-of-viagra-spot-highlighting-absurdity-of-continued-gender-inequity-in-sexual-health-279470512.html
I found this on the ANIP board and I believe this upcoming conference and incredible video are part of the reason for the move north.
I have signed the petition. Have you?
Silvr
Thank you very much for reminding us all about the upcoming conference and THAT VIDEO IS HILARIOUS and perfectly timed. I'm going to post it on the APRI board because of Femprox (not competition with Libigel IMO-both products needed).
Thank you too JTFM. Still here awaiting a rocket in the pps.
To all ANI/Biosante followers... Have you signed the petition? I have. Best of luck everyone!
"The New Zealand researchers discovered than an active ingredient called sildenafil can inhibit an enzyme which is important for transmitting light signals from the retina to the brain."
My understanding is that if the active ingredient sildenafil is removed from the viagra formula, viagra does not work for its intended purpose.
Benefit of viagra may not outweigh risk of melanoma
http://www.aboutlawsuits.com/viagra-melanoma-risks-erectile-dysfunction-benefits-70799/
JTFM
Thanks for responding. It's pretty interesting that such a complicated pay to delay was uncovered. I agree. Probably no benefit to the little guy.
Better article may be an explanation about mysterious Tesneo
http://www.fiercepharma.com/story/ftc-takes-after-abbvie-teva-pay-delay-deal-androgel/2014-09-08