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It's interesting that Jason Gerberry thinks our drug won't "dent" Mallinkrodt's market. In August M- reported that sales were disappointing because insurers wouldn't pay because theirs was too expensive. Ours will be less expensive. Again, out CEO seems to have found a valuable niche.
http://finance.yahoo.com/news/mallinckrodt-slumps-trimming-sales-forecast-174313070.html
JTFM
I've been following your dialogue on YMB, thanks for that. You mentioned cmax (IDT). I found the following Susan Davis research that demonstates the importance of transdermal T appliction site AND references cmax (although premenopausal women):
http://www.researchgate.net/publication/264241666_Application_Site_Affects_the_Pharmacokinetics_of_Topical_Testosterone_Applied_to_the_Axilla_Compared_With_the_Inner_Arm
Interesting that Libigel was applied to the "upper arm" in BPAX studies when compounding pharmacists tell patients to apply compounded creams to "thin skinned areas like inner arm". As a patch, Intrinsa was applied to the abdomen.
Susan Davis' research is saying the armpit (axilla) is most effective. Makes me wonder why the upper arm was determined to be the application site for Libigel? Hmmm.
Thanks JTFM
Seizure med.
Thanks.
JTFM
Thanks for the IDT info. If anyone has trouble finding the list, go to the drop down menu, select investor, then presentation.
Do you think IDT is interested in Libigel? Just wondering because the successful clinical studies regarding cognitive function/memory were conducted in Australia AND Australia already sells an approved testosterone cream for women called Androfeme.
http://www.news-medical.net/news/20100713/Clinical-trial-initiated-to-evaluate-LibiGel-on-cognitive-function-in-menopausal-women.aspx
Thank you Al. Appreciate it.
Thank you. Sorry to have misused the "r" word; very different meaning.
I called Computershare today and they did a search with my ss# and got no results.
The rep had no knowledge of CVRs held by ANI or Biosante.
JTFM
Q: libigel began as a partnership between BPAX/ATRS (then AIS). If cv patent application was filed AFTER FDA rejection what terms of partnership still exist if patent is granted? Thanks.
Nothing in my accounts either: etrade and fidelity.
I hope you're right. Another scenario is that an acquiring company wants the distribution done.
In any event this fall is beginning to heat up.
I hope you guys are right and money is coming soon!
I keep thinking that they moved the documentation into shareholder accounts because they're sick of answering questions about the details and the whereabouts of CVRs.
Best of luck!!
Computershare is the name of the company.
Hi Mace
They are not yet in my Fidelity acct either. I also use etrade. As of last night, not there either.
Hope so. If not, Libigel will be developed in another way. Too valuable to ignore.
JTFM
Great speculation. Thank you for connecting dots. Best of luck!
Why wouldn't they just buy us to regain generics that they just sold to teva? And gain access to Libigel?
Thanks.
There must be something in the works to which we are not privy. Growing eemt sales? C'mon. We all know what the "mt"is all about. 4 million off label scripts. Really.
Hopefully we will hear something soon.
Great info. Thanks Jeff!
Don't forget about GVAX
http://www.barrons.com/this_week?mod=BOL_Nav_MAG_hpp
CANCER: THE NEW CURE
OPK. It's the only one left! Down at the close. Oh well...
I don't understand either but it's not like this hasn't happened before with recovery.
We have an excellent CEO who just countered a slight earnings miss with a new deal abroad.
After all we have been through this isn't a tragedy.
Off topic: The OPK/BRLI acquisition has similarities to our merger in that OPK is heavy into intellectual property and BRLI is a major revenue producer. I bought today and maybe I'll regret it but do you or anyone else have insight? Thanks.
If it's okay to pull up old stuff, here's a Medscape article dated 2012 that quotes Irwin Goldstein and James Simon, two experts and key opinion leaders (as in the FDA listens to their opinions!).
Although conducted primarily in China, it's compelling.
http://www.medscape.com/viewarticle/764590
Treatments for female sexual problems are finally having their day in the sun. Ee/mt is one product that no one is talking about. We are in very good position. Patience.
Why the rush? A race against Intrinsa?
Are women using Vitaros "off label" as they would be able to use Femprox? Any info on this?
Thanks.
I agree about Dr. Snabes.
All these companies have been waiting in the wings for the FDA decision on Sprout's product. The green light is flashing! I am certain that if the FDA had any real objections to Libigel and/orIntrinsa (in this current research/political/economic climate) they would be all over ANI for selling ee/mt, and obviously they don't.
Thanks.
The article makes it sound like it is for pediatric treatments.
It's a PEDIATRIC priority review voucher.
http://www.marketwatch.com/story/united-therapeutics-corporation-agrees-to-sell-priority-review-voucher-to-abbvie-for-350-million-2015-08-19
How do you envision Abbvie acquiring our data to use in a priority review?
That's entirely possible! Apricus Biosciences put it out there today:http://www.marketwatch.com/story/apricus-biosciences-announces-it-is-seeking-a-global-partner-for-femprox-a-novel-treatment-for-female-sexual-dysfunction-2015-08-19
Libigel would serve a much broader patient base than flibanserin. Does your hypothesis include a company buyout?
Thanks JTFM
AU:IDT pps has risen steadily since announcement.
IDT up 12.7% on Australian exchange.
http://en.idtaus.com.au/investor-centre/share-price/
With nothing under "news" on Marketwatch. Am I looking at this right?
Thank you!
So interesting.
Eleven years later it is laughable that Intrinsa was rejected because the FDA feared "off label use." Instead women have been presribed men's testosterone "off label." Hopefully in 2015 the FDA will be able to see the irony of their 2004 rejection.
Our safety data is the missing link. Thanks!
Great article. Great post. Thank you!
Thanks Silvr and JTFM
Great news about our company!
Here is an interesting possibility for the future of lithobid:http://www.nursingtimes.net/nursing-practice/specialisms/older-people/lithium-shows-promise-as-arthritis-treatment/5088074.article
I've wondered about our possible alliance with OPko after noticing all the BPAX employees that have also been employed there.
Could these drugs be Dr. Frost's parting gifts from TEVA for his future megapharma OPKO that may include ANI as a generic drug arm?
Just wondering.