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Somebody once told me you need balls the size of grapefruits to survive the ups and downs of a biotech stock. I myself find that I drink more than I used to. What this has taught me is that there will always be the person who claims that they have sold at just at the right time after the SP has gone down. Of course, if it had gone up, you would never have heard from them. I read the information here, and then make my own decision, as everyone should. Todays action was classic manipulation. People had their stops taken out so fast that they didn't know what happened. Grow some balls, and then make your decision. Good luck to all.
What just happened? Anyone know of a pr release?
Hi Homeslice. Simes did say that but every time he did there was more and I quote from his last prensentation "Libigel had the intended effect of increasing the number of satisfying sexual events, unfortunately, the placebo did as well and so we could not show a difference" He never did say one without the other but I wish he had. I would have retired :) I realize this is the reason for the change of protocol on any upcoming efficacy trials.
Hi Pete. Hope you are doing well my friend. GLTY.
Thanks JTFM. And thanks to all for the info on this board. I get just enough time here to try to keep up and wish I could contribute as much as you guys do. I hope everyone here appreciates your time and efforts. Thanks again.
Al
Hi Win. Yes, the Professor may be exactly right. What I am saying is it is not legal. Of course, now in this country rather than obey the law, we set aside money to defend what we have done. Simes said at his last conference presentation that it is business as usual for Bpax. Then release the Safety Data or if there is none, explain why. Bpax is still trading and they must tell the stockholders this information or risk the lawsuits that are sure to come. Of course, business as usual for bpax is tell the shareholders nothing!
Question for the board. If Bpax has safety results for Libigel, don't they have a legal obligation to release these results, regardless of any pending mergers or sale of this product? They are still trading as Bpax. This information could and probably will affect share price. I do not believe they can legally hold results from shareholders if they have them. And like Jeff, if they do not have them, I am wondering what the delay is.
For no reason I can give you other than to attract buyers on the way up, and get their shares on the way down, I think we may be headed back to where we were several weeks ago.
Diannedawn.
I agree. If there is information, good or bad, on safety results for Libigel, they must release them, in a perfect world anyway.
Win
Didn't know you were from Allentown area. I'm from Hamburg.
D.D. I hear you man and I am here to the end, what ever that might be.
Donenberg's reply
Notice I did not ask any questions about the merger, only about Libigel Safety Trial. He kept refering to the merger. Obviously my questions were never read. Just a standard form letter given to everyone. The reply came back way to fast.
Letter to Phil Donenberg
I sent these questions to Donenberg.
Mr. Donenberg. As an investor in Biosante, I have several questions.
1. If the Libigel Safety Review has concluded, why is Biosante still blinded from the results?
2. Who will review or is reviewing the results?
3 Do you have a time frame as to when these result will be made public?
I thank you in advance for your prompt reply sir.
His answer.
Thank you for your continued interest in BioSante, Mr. Kershner. And your investment confidence.
In view of our pending merger with ANI Pharmaceuticals, Inc. and anticipated filings we will need to make with the SEC in connection with the transaction, we are quite limited in what we can say about the merger and about the company post-merger. Therefore, we are forced just to refer you to our news release dated October 4, 2012 and Form 8-K filing from the same day as well as the actual transaction documents that were attached as exhibits to the Form 8-K. An Form S-4 registration statement will be filed with the SEC by BioSante in connection with the transaction. That document will contain additional information regarding the transaction, BioSante, ANI and the combined company that will result from the merger. We encourage you to review the Form S-4 once it is filed
Thanks professor.
I am trying to understand this.
Simes said an independent data monitoring committee conducted nine unblinded reviews with no safety issues raised. Now they have ended the safety study because hopefully they are very confident in the outcome. Are they saying that they now review the data. It would seem to me that again, an independent committee would do the review. I don't think BioSante saying "yep,looks good to us" would cut it. Am I on the wrong track here?
Professor That's what I was waiting to hear.An update on release of safety data. Not a word?
Looks like same old same old :( No help from Simes
Mr D.D. I wish it was 775 million. I see 16 million in 2011.
Contract manufacturing probably being key word but not.a very large company. Anyone ever heard of them?
Pretty obvious there is no more shares to be had. Those who have are holding. I am. Go ahead and short this :)
Professor. Maybe we are better off with no news and just let this happen.
I don,t think the change is a big surprise. I remember Simes said at one of his presentations at the beginning of the year that he did not know what Teva would call it.
JTFM. Yea, your right , but tell me this does't suck. Manibulation and decebtion seems to be the standard now. Thanks for all your D D man.
So let me get this straight. Everyone seems to think as far as a buyout, they will get next to nothing for everything in their pipeline, and all the years of development meant nothing at all?
Thanks Beandog for taking the time and sharing that.
Second answer to email to Antares.
This is a second answer I got today from an email I sent om Aug. 9th as to Libigel being listed in their pipeline.
Hi Al. BioSante owns this asset – and we are entitled to a royalty from them if the product ever gets approved. As such, we have added it back to our pipeline chart – however – we will not be providing any updates or timelines on this product as we do not control the clinical trial activity. Only BioSante will be providing updates as they see fit.
I hope this helps.
Regards,
Jack Howarth
Vice President Corporate Affairs
100 Princeton South, Suite 300
Ewing New Jersey 08628
Homeslice. I know equipment is expensive. The point I was trying to make was I do not believe the answer we got from Donenberg about the use of. the packaging machine. They did not purchase it for use in trials. You do not park it in the corner of the office and away we go
Exactly. It was certainly not going to be used for packaging for any trials. And I question, as you do, if they even have it yet. I just wish we could get some straight answers from management.
What I meant was considering the date that they bought it, they could not have used it alot for any of the trials, saftey or efficacy, if they used it at all. And even with the continuing safety trial and new efficacy trials, how much would you need to package?
"This equipment is used to package LibiGel in its metered-dose bottle in commercial quantities."
As opposed to what, packaging for the trials? This answer makes no sense at all. Do you mean to tell me they contracted the manufacture of Libigel out but they packaged it? At a cost of $847,532, what were they doing, saving money?
My questions and Donenberg's answers
I noticed on the 10Q report that Biosante purchaced a gel packaging machine at the cost of $847,532. What is the intended purpose for this equipment?
This equipment is used to package LibiGel in its metered-dose bottle in commercial quantities.
Will it be used for the manufacture of BioTgel, Libigel or both?
This machine solely is for packaging of LibiGel.
Also, why are the positions of Q & A , CAPA, and SAFETY, being filled? Is this in preparation for manufacturing or are they needed for an upcoming NDA submittal or required for the new Libigel PH3 efficacy trials?
The posted positions are to build BioSante’s clinical team.
And lastly, Does Biosante have any definite plans for manufacturing BioTgel or Libigel?
LibiGel has been manufactured for years for use in the Phase III clinical Studies. Testosterone gel (formerly Bio-T-Gel) manufacturing is the responsibility of Teva, our licensee.
I thank you in advance for your prompt reply
Jeff. I also got no response. You don't even get a "go get f***ed answer :)
Both Yahoo and Ihub boards in quiet mode, just like Bpax. Not even bashers are around. LOL
Thanks for sharing Homeslice.
Thanks Professor. I have used your questions in my email. I will post the reply if and when I get it.
Thanks Beandog.
Does anyone remember what the cost was of the gel equipment and when did they report it? It seems to me it was the beginning of the year after the news in December. I think we should just ask why they purchased it. Help me word the questions to be ask. Yea, they will probably dance around it, but it seems to me it was quite a bit of money, so for the record, lets ask.
Retirement sounds great Pete. I just turned 59 this week. Put in for an early retirement package that they offered 2 years ago and I think I was the only person in the whole corporation that they said no to. I was totally bummed out. was hoping BPAX would do it for me.
Agreed.
Jeff. Again here is their response to my email. If this was put in their pipeline list by mistake, their PR guy must be in on it!
Al - thanks for your question. We have a partnership with BioSante on LibiGel. Since it is their asset, and our primary focus is on internal projects only we can control, they will be providing updates.
Thank you for your question.
Regards,
Jack Howarth