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That what I figure too. But the difference is I see the pps going up after r/s with ANIP earnings instead of down like it did after BPAX last r/s and no revenue. Where are we going to get cash? Bio T gel? Please. We got nothing but long term goals and patents. Pie in the sky.,
JMO but I see ANI in good hands with Przybyl.
May not be overnight magic show but much better long term forecast.
Best of luck to all longs!
L
I appreciate your response.
why would the merger be kissing your money goodbye? ANI has revenue and they are a hormone manufacturer.
Is it that you think we are undervalued heading into the merger? I am certain that Libigel will eventually make money but it will be expensive making that happen.
Please explain why you are so sure. Thanks.
Win
I want to merge because we are going down the drain with no revenue. My feeling is that we need to get into a green position before we can make a move forward. Without ANI we are looking at another r/s anyway. Fast cash burn.
Fridays CVR announcement was a + move and Dr Sullivan stepped up to the mike to let shareholdersknow that the BOD support of merger was unanimous. I am in a deeper hole than most having invested pre-12/11.
Because of FDA I believe we are more vulnerable than some others here seem to believe. I still believe Libigel will gain approval but I am willing to share that with ANI for the security and revenue they have to offer.
Sound conservative? I have big chunk of change here.
Message to JTFM: In a recent post did you say you have only 3000 shares?
I have a habit of over-thinking this stuff but Dr. Michael Snabes is leaving. Is it possible that we are finished with Libigel clinical trials? He has been in charge of clinical trials since the beginning.
A message in the 8-k.
One would think so...
At this point we have to evaluate the info at hand and go with our gut.
This is a leap. What I hope is that we get a big fat catalyst between now and friday!
JTFM
I'm sure there was a period of negotiation before the BOD made their final decision on the terms of the merger.
You either believe that Dr Louis Sullivan;Dr.Stephen Sherwin;Dr.John Potts;Dr.Rosenow;and others are acting ethically on behalf of the company shareholders and it's intellectual property or you do not.
Best of luck to all longs.
Let me start by saying I respect your opinion and I have appreciated all the work you have done to inform this board.
I know efficacy seems obvious but according to Simes the FDA viewed our efficacy as problematic. If the SPA design was flawed, and I believe it was, we were slammed by the FDA, not our own company.
This could all turn around and we could get approval. From the digging I have done and posted, "key opinion leaders" think the FDA is being ridiculous. I happen to believe that BPAX gave it their best shot.
Personally I think we should have access to EVERY FDA correspondence as public information but good luck with that.
I voted yes for the r/s. We need to stay listed on the NASDAQ. To lose that, even when we become ANIP would be losing an enormous asset.
That is a big part of why ANI wanted us in the first place.
The devil is always in the details folks.
I agree. We don't know. It's just going to cost big $ to find out.
Hi Jeff,
Believe me, I share your frustration.
It was failed efficacy that sunk this ship in December 2011 and successful safety did not raise it.
Follow the money.
JTFM/Jeff and all
Warner Chilcott stopped selling Intrinsa, an approved product in Europe "for commercial reasons"What does that mean? No other big pharma bought Intrinsa.
I voted for the merger and I know it's an unpopular position on this board.
I think that BPAX has tried to come up with a revenue producing solution for the co and now that they have found one we are confined by time constraints; cash already directed toward this project and legal fees; and the company's mental change of direction.
I believe we are going to be okay in time. I have based my decision on the info in the printed SEC materials; the recommendations from 3 companys and from Mr Simes comments that you have shared. I thank you for that.
I have worked with gov contracts and there is always a body of info that cannot legally be disclosed. If there was dissent amongst the Directors my suspicions would be alerted. This is not the case.
Best of luck and best wishes to all investors here.
Thanks for explaining.
RG
Is it typical that not voting would be the same as a NO vote in a situation like this?
Just wondered if you knew if these were unusual circumstances. Thanks.
I have wondered about the Antares relationship for a while. The two companies are very quiet about any current relationship.
I rec'd this email from Donenberg and posted it at the time. Does this shed light on whether or not Antares is involved in the case of the sale of an unapproved product?
From January 2012
Q:I have a question about the new patent application filings: 20120004204 and 20120022033. In each case, is the gel suspension a formula patent owned by Antares Pharma?
A:The patent applications you site are broadly directed to using any transdermal testosterone formulation for decreasing CV risk, including existing formulations for male products, as well as formulations to which BioSante has rights, e.g., the Antares formulation.
There have been so many clinical trials some of which have allowed concommittant estrogen. Is it possible BPAX has collected the data for patients using both estrogen and testosterone and they are planning to sell a gel version of Estratest?
I have already voted for the merger but I am watching closely and would certainly consider changing my vote if this thing starts to smell any worse.
Palatin PTN got a pop today because of data presented from the ISSWSH Annual Meeting.
Maybe Susan Davis'presentation and data tomorrow isn't such a long shot for us to have a pop next week?
I forgot to include:
THIS SATURDAY
State-of-the-Art Lecture #4: Testosterone Use in Pre- and
Postmenopausal Women
Introduction: Alan Altman, MD
Speaker: Susan R. Davis, MBBS, FRACP, PhD
at the ISSWSH annual meeting. It's a long shot. Cross your fingers for a PR next week.
Hi Jeff,
Thank you sharing your conversation with Stephen Simes. Great info.
It looks like Big Pharma in Europe and UK is not interested in T therapy for women either citing commercial reasons:
http://www.thebms.org.uk/newsitem.php?newsid=67
Apparently not enough money in it.
I think it is unreasonable to ask S. Simes to go on record saying that Abbott/Abbvie is not interested. That is not his position to speak for another company's interests.
Even though I am underwater as an investor who did not have the opportunity to get out pre-efficacy info, I would like to go on record as saying that I really appreciate what Biosante has attempted to accomplish with years and years of clinical trials.
I have noted through past postings that the experts in the OB/GYN medical community have supported Biosante and Libigel.
It is depressing to me that in 2013 women's sexual health is still so marginalized. It is really a bigger cultural issue IMO and time for the FDA to do some real soul-searching before they ask us or another company to empty their pockets to jump through these efficacy hoops when the numbers of women seeking compounded scripts is exploding! It works already! Biosante has established safety at this tiny required dosage.
Ironically business is booming for the compounding pharmacists and my hope is that ANI gets a piece of that.
FYI I just voted for all proposals.
Here's a link to ablog from the UK. Women trying to figure out what to use now that they can't get intrinsa. Eyeballing a "pea-sized" dosage of men's T gel. How's that for safety? I don't think so.
http://www.menopausematters.co.uk/forum/index.php?topic=21356.0
A little devil's advocacy-
Some positive points:
The company CEO is calling retail shareholders to answer questions. C'mon. Could be contracting with some phone answering company. I'm impressed.
Pryzbyl is a can-do new CEO.
ANI is already making money. We will have an earnings report with actual revenue.
ANI manufacturers the same kind of products we have as approved products and pipeline. Compatibility.
Company has made staying on NASDAQ a priority. Would you have bought in the first place if this wasn't on NASDAQ. I would not have.
There are a lot of unanswered questions about royalties and milestones. Honestly I own other biotechs in partnerships and they have not disclosed all of those terms either. If our pps was great we wouldn't be making a big deal about it.
I'm still processing all of this too but JTFM's post gave us a reality check and I thank him for it.
Abbott doesn't want Libigel. Intrinsa pulled in Europe and UK for commercial reasons. Who will go out on that limb? ANI?
Fire up that gel filling machine. I think we may be selling it unapproved. Why not?
Thank you for sharing this info! Great post JTFM!
Is it possible that all this ambiguity was put in place intentionally to prompt a NO vote?
Just the fact that we just had a 1:6 r/s and now we're heading into another with a yet to be determined ratio?
Being told to vote YES by a firm (Egan-Jones) that has just had a ton of bad press questioning their ethics.
Publication after publication with experts attesting to the efficacy of T for women and yet a low valuation for Libigl?
Is there another example out there where a company did just this? Just like we read one Monday morning that GVAX had been sold; we could read one day that Libigel is sold pre-merger and the CVRs are just a red herring fakeout.
I am waiting until the last day to vote. Too much drama still unfolding. I really want to hear what Susan Davis has to say next week.
I got mine from etrade about 10 days ago.
An update on the pharmacological management of female sexual dysfunction
October 2012, Vol. 13, No. 15 , Pages 2131-2142 (doi:10.1517/14656566.2012.725046)
HTML PDF (241 KB) PDF Plus (325 KB) Reprints PermissionsEnsieh Fooladi †1 MSc & Susan R Davis2 MBBS FRACP PhD
1 Women's Health Program, School of Public Health and Preventive Medicine, Monash University, Level 6, the Alfred Centre, 99 Commercial Road, Melbourne, Victoria, 3004, Australia +61 03 99030374 99030827; +61 03 99030828; Ensieh.Fooladi@monash.edu
2Australian NHMRC Principal Research Fellow (Grant no. 490939), Monash University, School of Public Health and Preventive Medicine, Women's Health Research Program, Level 6, the Alfred Centre, 99 Commercial Road, Melbourne, Vic, 3004, Australia
†Author for correspondence
Introduction: Female sexual dysfunction (FSD) is a global health issue, with as many as 12% of women over 18 years old reporting sexual difficulties associated with distress. It is a multifaceted problem with psychological and biological causes. Affected women tend to have an impaired quality of life, a decreased level of well-being and relationship issues. Hence there is a need for management options for affected women.
Areas covered: This paper focuses on current pharmacological options for the treatment of FSD, particularly estrogens and androgens, which have been extensively studied. Some investigational drugs are also described, including the centrally acting agents such as flibanserin and bupropion, and intravaginal DHEA and testosterone, which may be useful as an alternative for women with specific conditions, such as breast cancer survivors.
Expert opinion: Although approval for the use of testosterone for treatment of FSD is limited to some European countries and restricted to surgically menopausal women, there is extensive off-label use for this purpose. No other product has yet achieved regulatory approval for treatment of FSD. Completion of studies of nonhormonal FSD therapies and safety studies of testosterone may result in regulatory approval of such products for the treatment of FSD in the near future.
Read More: http://informahealthcare.com/doi/abs/10.1517/14656566.2012.725046
Mr.Simes
Considering the fact that ANI already sells a testosterone based product for women (Estratest) that is not FDA approved, what specific barriers would the new company encounter if there was a decision to sell non FDA approved Libigel?
If that were to happen how would the partnership with Antares Pharma be affected?
What are the "sales milestones" in the Elestrin deal?
Lol. I didn't mean you!
I just meant it must be pretty easy to get addicted because there sure are plenty of people who do.
Meanwhile there has been a lot written about pain meds causing T deficiency. Did not know that.
GLTA
Pete,
Good for you to stay so positive! I too have know many with pain med addiction-young and old.
J
http://www.ncbi.nlm.nih.gov/pubmed/22786453
This is an interesting abstract about opioid-induced testosterone deficiency in both men and women. Actually has it's own name as a condition: OPIAD Opioid Associated Androgen Deficiency.
Recommendation: T "replacement therapy."
Consider ANI involvement here in both the pain med and the T therapy.
Have you read the history of the guy who started Biosante; back when it was called Ben Abraham Technologies? It is the stuff of Sci Fi. I was reading it over the weekend. Maybe GVAX was being protected from Dr. Evil (not porgyrusty).
I can't copy andpaste from here. Google Chicago Tribune Avi Ben-Abraham.
Our CVRs are not going to be separately tradeable like that. Was that decision made because it could potentially be a huge distraction from ANIP pps ifLibigel was to be very successful?
Im thinking that Libigel news may be coming soon. Michael Snabes and S Simes have presented about Libigel at almost every ISSWSH cojference in recent past. Last years presentation was "Libigel Clear Path to Approval" AFTER efficacy issue. Susan Davis is the presenter. End of Feb.
This tiny tablet is impossible. G L!/
OurCVRs
Makes sense.
I appreciate your vigilance.
That's great. Lets have a good day tomorrow. GLTA
My etrade acct says Blackrock Institutional Trust owns 598.9K shares.
OK Tribune
Are you buying now? I'm a little gun shy that there may be too much time between now and the actual merger.
On the other hand shouldn't we be getting updates about Pill Plus or Ceregene?
I noticed on the website they completely removed Elestrin from partnership page.
Nice find. It's interesting to see what else they are and are not buying. I guess that explains the recent rise in pps. Those who know before the plebians.
Best of luck JTFM and all BPAX longs. Looking forward to a new stock symbol.
Women without ovaries have far greater risk of developing M.S.
New study suggests that testosterone supplementation helps as treatment for M.S.
http://www.sciencedaily.com/releases/2013/01/130130082728.htm
Hi Catty,
I guess what happens if Aduro is sold depends on the terms of the agreement. JTFM answered better than I could.
I guess this boils down to whether or not you believe that the company is operating with the best interest of shareholders in mind and believe it or not, I do.
So if you're reading this Big Steve, please know that I would love to retire some day and my youngest kid is still in college!
If this merger is all about products that are a good fit with ANI we may be hearing news about our stake in Ceregene.