[b]I hate to advocate drugs, alcohol, violence, or insanity to anyone, but they've always worked for me.[/b]
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Advaxis has a few things going for it.
#1) Big Pharma looking for pipelines to new drugs, delivery mechanisms, or an existing platform (which Advaxis has) that can be coupled to existing therapeutics Big Pharma has.
#2) As mentioned Advaxis has a platform that is synergistic to other therapies. While adding vaccine type properties to the patient with little to no side effects it can help other therapies more efficiently.
3) This platform can be used on a wide variety of diseases, cancer types being one.
4) Advaxis has had good results on their platform. If they had not nobody would bother to hold this stock including institutional investors.
5) Institutional investment firms do their research before they dive in. They have done their DD on ADXS and continue to hold.
There is a reason why everyone is holding.
A buyout is very possible. All it will take is one proof of concept in my opinion.
Have been looking at ADXS since 2010 going back to the Yvonne Paterson
U of Penn days.
Have noticed insiders, even those who have left for other places, have not sold any shares. The current CEO who is leaving is still collecting shares.
With all of the institutional investors still on board and those who plunked many shares into mutual funds, makes me wonder what is going on
at Advaxis.
With all that I have posted there is one conclusion I have come to.
That conclusion is that ADXS technology is still very viable.
There are probably a multitude of opportunities with Big Pharma.
If things were dire at ADXS insiders would have been selling off.
Institutional investors would also more than likely look for a point at which to leave.
So far,,, not happening.
Highly manipulated stock I have my eye on. Just my opinion.
ANDA for OxyContin will be huge for Elite.
Only a 1% market penetration for their generic OxyContin could give Elite
$25 million in revenue. Likely to be much more than 1% market penetration.
A generic will cost much less than the branded. 1% is very conservative to say the least.
There are many many algorithmic computers doing this all day, everyday.
Thanks rojack.
Think I did read an excerpt in a published finding similar to that in JAMA a time or two Maz.
Yeah baby! That's what I'm talking about! This partnership is going to be very good for both companies.
Lasers, the partnership with SunGen looks to be flourishing.
Apparently they like what Elite has done for them so far.
Now give us that OxyContin ANDA.
So Couch... with your newly acquired shares...... how much have you made just on those alone? 19 percent?
Not bad my friend.... not bad at all.
That's what I keep saying! Big Pharma can only lobby so much to stave off ADF competition. Big Pharma is losing its power to hundreds of deaths each year and growing.
As lasers has pointed out many times there are numerous IR opioids with Tmax problems which carry a pamphlet of instructions when and when not to take.
I believe the number is about 60......
Crazy? Not hardly!
This is hardly a policy matter. So yes would be the most likely
answer.
I agree with Lasers.
When the pressure is on the first action is limiting the supply
of pain meds. Gottlieb is considering that. The other action is better understanding of pain management.... training to ALL healthcare professionals Gottlieb is also considering.... as if these professionals don't get enough training in school... but this too he is considering.
What more can he do other than try to get approval on some ADF opioids that can start to squelch the problem?
Lawsuits already on the horizon against Big Pharmas that manufacture these prescription opioids without ADFs.
Re-read the PR. You were right lasers.
We will just have to wait this out.
The onus is not on the FDA. That's not how it works.
The reality is this, NH knew of Tmax problems the first go around with SequestOx. This was brought up before the FDA. FDA in turn said no worries, it's a labeling issue. They go ahead with submitting test results and FDA does a 180.... opps we need better Tmax. Not a labeling issue at all.
Who's getting jerked around here Maz?
Listen, the ONUS is on the FDA. The FDA can do whatever it wants with respect to granting approvals.
Do you know first hand what happened during testing? Do you have inside information Camargo messed up? Then spill it.
No hear say. You do not know a THING! Just your opinion of what transpired.
Notice the lack of a question mark.
Sure hope lots of folks shorted this stock. The squeeze is going to be a wonderful sight.
Generic OxyContin will be cheaper by the dozen. LOL
Purdue will take a beating when other pharmas start producing generic versions of their formulation. Can't wait.
Actually I believe Lasers may be right, in an effort to reduce cost
Elite will first meet with the FDA to discuss the results. Get guidance from the FDA and go from there.
Don't forget that SequestOx cannot be smoked either.
Labeling CAN be revisited and a labeling instruction given along with the drug. All of this done while Elite reworks its formulation
if the FDA wants this to happen. It is all up to the FDA.
OR the FDA can just give Elite approval with labeling instruction on the current version. All up to the FDA. Ball is in their court.
And where would this "better tech" be pray tell? TIA
Where a label warning can be applied I really see no problem, however, others will see a problem because they do not want this formulation on the market. It will interfere with their profit.
thanks for your input Lasers.
Personally I think the market over reacted on Friday.
Lots of good things still to come.
AND Elite will still be meeting with the FDA about SequestOx.
Under Gottlieb labeling may yet be revisited because YES Virginia
the crisis is just that bad. NOBODY has anything close to an answer.... with the exception of Elite Pharmaceuticals. Maybe Lasers is right about this. I have no idea.
Disappointing Tmax results that can easily be rectified with labeling. Well golly gee imagine that!
As for the major Pharmas like Pfizer and Purdue..... they have ZERO
ADF products yet continue to pump out addictive opioids by the ton.....
with the exception of tamper resistant OxyContin. And what a joke that is. A $2.5 billion dollar opioid joke that can be abused quite easily. FDA has made it so that Purdue does not get the total piece of the pie for their formulation. Tamper resistant
just does not cut it anymore. FDA nixed Opana because it too was a joke easily abused. And Endo had the solution according to some who post here. Well, where is this solution now? Down the toilet, that's where.
So the bottom line here is what Elite has in their current pipeline
and what the FDA needs to do with the IR version of Elite's
ADF.
The onus is actually on the FDA. Squarely on their shoulders,
not on Elite's shoulders. Up until now Elite has done everything they could do. If Elite gets approval of this version with a labeling contingency until they can possibly reformulate again, I would say that is a distinct possibility. And if that reformulation fails then Elite has to carry the labeling forward
with what they have. It IS just that simple. No politics, just act and do the right thing. FDA has nothing to lose while buying time for possibly a better formulation for Tmax.
It is a no brainer.
The FDA will have to get creative if they want to truly curtail this epidemic Big Pharma has created and Big Pharma has no answer for. Mr. Gottlieb the ball is in your court. Deal now or wait years with no guarantee of an answer. Labeling revisited, or scrap everything with no IR solution.
I think the answer is very clear here.
Alfonso31, the FDA does have a choice here. They were willing to go with labeling before this whole fat heavy meal came into play, then did a 180 on Elite.
With enough time, and with monies coming in to cover the cost of further testing I believe Elite CAN reformulate and get acceptable
Tmax results. 1 hour and 12 minutes time average over comparator is not that big of a gap IMO.
Corpus, thank you. This is the way I see it. Under Califf Elite would still have to prove SequestOx Tmax results to be within
what they consider safe..... with no labeling to be considered.
Under Gottlieb maybe that will change. IMO it should with the contingency that Elite still continue to work on this formulation to get Tmax closer/better than the comparator otherwise SequestOx
carries labeling.
Lorie, explanation is simple. They knew I bought more shares right before 12 noon.
Then the Whammy. And that's my take on it.
Wonder what that guy that Nasrat sat down with during Valentine's Day said to him.
Not being confrontational Lasers, but if what you imply is true, that the data presented in the PR is from the original testing, my question would be where is the reformulated SequestOx data in the PR? Why wasn't it presented as reformulated versus original formulation?
That if what you imply is true... this PR it is poorly written IF your assumption is correct.
Don't think this to be the case though.
A one hour and 12 minute (average)(1.2 hours) more than the comparator.
Would be nice if you were right though. Maybe NH should do a mini
CC.
Yes. Agreed. It is gambling.
As providers we're facing unprecedented cuts across many states in the total morphine equivalents we can prescribe to patients with chronic severe pain; without suitable alternatives. And these cuts are solely due to abuse concerns. Seriously WTF FDA?
I understand the science failed us with regards to fixing the TMax issue, but the ADT formulation STILL WORKS.
To each his/her own. Trade, buy, sell, whatever.
This product is needed on the front lines by providers and patients.
--Nasrat Hakim
4 years before sentencing for stock fraud
Well Lorie, this company is not a one trick pony that is for sure, thank goodness.
And as I just posted to Lasers, SequestOx is not a goner by any stretch. We have a new guy in charge of the FDA. Let's see what he has to say about SequestOx when Elite meets with the FDA.
Good observation about the press release timing.
Fingers crossed.......
IMO there most definitely is FDA and $ELTP discussions to get Reformulated SequestOx ASAP without any further testing and monies.
But the PR most definitely does NOt give the statistics for the Reformulated SequestOx
NH lost lots more than either of us peons Couch.
Still not selling. After they meet with the FDA and get some guidance it will be up to the powers that be to decide what to do.... not any of us.
If this is as you say Lasers.... then this was one time to buy
and one heck of a head fake.
Thanks for your input.
Understood, but why would NH go on to say “We were hoping for better and more decisive results for the reformulated immediate release version of SequestOxTM”, said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “We remain positive with respect to Elite’s abuse-deterrent and generic pipeline. We will see the results of our hard work over the next six to twelve months.”
Why could the PR not just state what the old results were and that the new BE results are being submitted to the FDA for review.
This PR makes no sense. Other top line results were released for other formulations such as OxyContin. In those PRs Elite came right out and said that the results were good.
Do you think NH is being super cautious not to say the reformulation is good or better than expected results because of past FDA decisions?
Otherwise this makes no sense. Why release any PR?
Don't have the transcript of the last CC but I thought I recalled NH stating that the results for Tmax were within FDA guidelines.
This is a poorly written PR IMO.