Mr. Phillip Donenberg, our CFO, recently responded to Matt's request for clarification regarding the change in submittable criteria for our LibiGel NDA.
His response stated that there had been no change in criteria for NDA submission, that confusion was a result of having achieved a 12 month average patient data much earlier than expected and that the time lines had not changed significantly.
On all three counts he is being disingenuous and his response is very unfortunate and does not engender trust, transparency and confidence in management.
On the first count has the criteria for NDA submission changed? Yes it has. Prior to this week the data criteria for submission included top line results from the two Phase III efficacy trials. They are expected in September and October. Additionally, we were to submit data from the safety trial. Supposedly, from the safety study the data must include at least a 12 month average patient treatment, at the time the study is fully enrolled.
This 12 month patient average was seen as critical and an FDA requirement before we could submit safety data for our NDA. CEO Simes in everyone of his webcasts made it a point to calculate "patient years" and "monthly patient average" because this was the FDA requirement for submitting the safety data in our NDA. In each webcast he made it a point to note we had achieved this 12 month average and as soon as the enrollment was complete we could submit the data in our NDA package.
Now we are told that we need an additional 12 more months of data in the safety study from the time the last patient was enrolled. This is a huge change and will impact our NDA, approval and launch timeline.
Under the guidelines prior to last week we had already achieved sufficient data from our safety trial. We were only waiting on the top line results from our efficacy trials which will be available in October 2011.
Assuming a rapid 4-5 month time frame to review and analyze the data, consultations with the FDA for feedback and enough time to put the lengthy NDA package together, we could have conceivably submitted our NDA in the first quarter of 2012. If we got a rapid 6-month review from the FDA we could have possibly been approved in the fourth quarter of 2012. Additionally, if a partnership had been established during this time, a launch of LibiGel could have, at least theoretically, been achieved by the end of 2012. And if you look at the 3/15/2011 webcast, slide 17, it states LibiGel launch in 2012.
This timeline is no longer possible. BioSante is now talking about submitting our NDA by the end of 2012, not launching in 2012. And remember BioSante's estimates for NDA submission have continuously slipped, as do most small biotech time lines. The launch timeline has now slipped by at least a year in my opinion.
Phil's statement that the confusion of time lines is a result of achieving a "12 month patient average ahead of schedule" is the dumbest and most blatantly disingenuous of his statements. He then goes on to say that the criteria for safety data submission always included 12 more months of data after the last patient enrolled.
If this is true we have been wasting our time with all those calculations of "patient years" and "average monthly patient" data. Continuing to collect safety data 12 months after the last patient enrolled would have guaranteed average 12 month patient data greater than 12 months. There would have been no need to constantly calculate patient years and average monthly patient data. Phil's statement is ridiculous, foolish and a pathetic attempt to claim there has been no change.
Phil's response is alarming. He obviously thinks we are incapable of performing basic math, our memories are short and we will unquestionably accept even the most inane explanations for timeline delays. Phil has not served BioSante well with his response. JMHO.
It is a good thing. We have provided shareholders a forum to vent their anger, outrage and frustrations with BioSante management. I hope management takes their concerns seriously. GLTY.
just to add to that, the initial review should go quick due to all the safety data they will have collected from over 3500 patients, which is the bright spot in all of this, is that management is dotting all of the i's and crossing all of the t's to make sure that it is definitely approved. as i have said before, the issue with other FDA panels before was the safety issue, so the more data the smoother the review should go.
to answer some of the questions....as phil said in his response nothing really changed from the may 31 press release. the pr said NDA would be in 2012, and the interview said by the end of 2012. like i said what i took from phil's response is that it is hard to pick a specific date because it depends on a # of factors. so you cannot honestly call them deceitful if they dont have a clear picture of when it will be submitted either, they can only give us the information as it comes to them. if the 12 months after final enrollment is in may next year, i said we might, i didn't by any means say it is guaranteed, that we could see a PDUFA in december of next year, if everything goes well. plus it wasn't their press release, they can't control how some third party website puts up the pr.
I can hardly believe what you just wrote. You think we can get approval in 2012. CEO Simes just gave an interview and told the world that we are on track to get an NDA by the end of 2012. BioSante has a track record of being overly optimistic. If you check the history of the company the NDA has now slipped two years.
At any rate maybe you can answer some of the following questions:
(1) Why did BioSante attempt to bury the new delay in a link inside an ostensibly positive press release? My gut feeling is they were trying to hide it. Why do you think that method for releasing a vital piece of information?
(2) Once BioSante management was called on it, why did they try to deny that a delay had taken place?
(3) Why did they try and claim that no change had taken place regarding NDA data submission?
(4) Why did Phil try and tell us the confusion stems from reaching the 12 month average patient exposure level much earlier than anticipated? This has got to be the dumbest, most disingenuous excuse (lie) ever from management.
If you are serious about thinking BioSante can receive approval by November 2012 please put down your time frame for NDA submission, review and analysis of two Phase III trials, the Study Trial, time needed for cosultation with the FDA, time to put a huge NDA application package together, review and approval time for FDA approval.
Thanks and GLTY.
i dont think that this is a matter of being deceitful, just a minor setback that may not turn out to be a setback at all. institutions know that this is par for the course, we have to jump through all of the FDA's loops to get that approval. what i took from phil's response is that they are not entirely sure when the product will be launched because it depends on a # of factors, when the NDA is submitted, how long the FDA reviews it, etc. you said it yourself 2 weeks ago that full enrollment was a huge milestone that essentially was the pre-approval for Libigel and took almost all of the risk off the table. i still believe that if we get priority review that we could see a PDUFA date in november or december of next year. let's not forget that we are 8 or 9 years into this....this is the 9th inning of a homefield game and we are up by 5 runs!!!
That they tried, unsuccessfully to bury it is one thing. When we called them on it and they tried to talk their way around it..well...
Very little respect for that. Not that they care, but come on now.
I guess we should just assume the worst from now on, therefore we won't be disappointed, ever.
You are making my point. I don't think large institutional investors care about the delay. You are the one that stated we should not issue a press release explaining the need to delay.
Chris, Matt, myself and others have stated BPAX should have issued a press release because it would not have affected the pps that much. You on the other hand seemed to think it would tank it.
What institutions and large investors get upset about is management being deceitful, dishonest and not being transparent. When management engages in that kind of behaviour that pps will drop and their credibility takes a hit.
P.S. If I had twenty million invested in this company and learned for the first time about the delay from the link buried in the press release or this message board I would have been furious. (Remember, I alerted this board minutes after the press release about the link and its contents.)
P.S. If you are stating that BPAX management alerted institutions and major investors before the press release yesterday, you are stating they are committing felonies and are guilty of insider trader laws. I do not think management is that corrupt or foolish. If you have evidence to the contrary please share it.