From last August -
Analyst - [ If you can get approval on the data coming up is it going to be conditional approval? Would you need to do a confirmatory trial? ]
Lewis - [ So I think we always want to plan for the need for additional data. And it certainly is worth remembering that in the interests of identifying the best clinical use of the drug additional work is always a prudent thing to plan for.
Having said that - I believe this study will stand on its own, and will be adequate for registration and approval. ]
[ I think anything that shows promise by way of reduction in bacterial density will be enough. ]
Imo the most important factor is the legislation passed last July - with the primary objective of encouraging the FDA to expedite the availability of drugs with data deemed "reasonably likely" to predict a clinical benefit in a serious or life-threatening condition where no therapy currently available can deliver said clinical benefit.
Amikacin - the antibiotic payload delivered by Arikace - is already routinely used in the treatment of drug-resistant pulmonary mycobacterial infections. Which essentially leaves this question for tomorrow -
How likely is it that the FDA will consider these results as "reasonably likely" to predict that Arikace can deliver an effective concentration of amikacin to a pulmonary mycobacterial infection more safely than is currently happening with amikacin injections?
Your opinion as to the answer is every bit as valid as the opinion of any analyst. But I suspect Lewis wasn't hyping the prospects when he ventured "anything that shows promise by way of reduction in bacterial density will be enough".
But bear in mind that the recommended period on antibiotics for patients such as those in this NTM study with a drug-resistant mycobacterial infection is 18-24 months.
It would be a major development if Arikace has managed to deliver a substantial reduction in bacterial density in just 3 months.
You must be really worried about the case for a JMOL of Non-infringement to persist in such a feeble attempt to switch the focus away from the facts.
I told you last time I'd repeat my answer just once a week, so here it is again -
[ Longprkr - I have no problem in answering your question about those ids.
But you can hardly expect me to offer straight answers to your questions when you refuse to offer straight answers to my questions.
You've avoided the following question thus far, claiming that it has already been answered. And yes, I did put that question to you - on March 16 -
"before you drown us all in your repetitive bloviation, I challenge each and every one of you to offer a straight response to the question I put to Tampa."
I'd be willing to be my house that you cannot.
But no ParkerVision pumper is about to admit that ParkerVision offered no evidence Judge Dalton could use as justifiable grounds for denying a JMOL of Non-infringement. ]
Longprkr - once again, kindly note that "I don't know the answer" is not acceptable.
If you're genuinely interested in receiving an answer to the question you've been asking me you only have to ask one of your fellow-Longs for the answer to my question -
"Please quote the evidence which placed an energy accumulation step as PART of the Qualcomm "method for down-converting a carrier signal to a baseband signal."
But you won't do that - because the whole point of asking your question is to divert attention away from inconvenient questions you fear your fellow-Longs can't answer.
Kudos Tampa - you're far braver than I am. I wouldn't lie to gain an advantage over another person anyway - but even for somebody who does, imo you're brave to post a lie as blatant as this -
"Even without the hours of detailed claim by claim testimony, that's evidence enough to deny QCOMS JMOL."
You didn't disagree with the point I made to you that evidence of down-conversion can only qualify as evidence of INFRINGING down-conversion if it is evidence that the accused products down-convert to baseband signal via the specific combination of steps patented by ParkerVision.
On numerous occasions I've pointed out to you that ParkerVision produced no evidence that the all-important patented energy accumulation steps are PART of the method by which the accused products down-convert to baseband signal.
You've never been able to cite contradictory evidence - unsurprising, given the acknowledgement of two witnesses that down-conversion occurs before the energy accumulation ParkerVision claimed occurs in the TX filter capacitor.
If Judge Dalton does indeed issue a JMOL of Non-infringement you'll be exposed as a blatant liar - as he cannot do so if there is any evidence of infringement.
But perhaps those of us who've been posting the truth have done you a big favour - in drawing attention to your lies.
Investors would have to be pretty dumb after all they've read here in recent months to rely upon pumper claims which have been so comprehensively debunked.
... is creating the illusion of "scoring points" - what does that say about their personalities, intelligence and the lives they lead?
Every time I see a point-scoring post it reminds me of stuff in my life I'd otherwise take for granted.
And talk about "fools rush in where angels fail to tread". I'll bet the possibility has never entered their tiny minds that there could be people of a vindictive nature out there holding considerable numbers of shares who have been influenced to do so by the pumpers' assurances that ParkerVision offered evidence of infringement - which would mean no possibility of Judge Dalton issuing a JMOL of Non-infringement catastrophic to the share price.
Or perhaps it has - but they're too dumb to realise that their anonymity would be a paper-thin defense against anybody with determination and enough cash to grease the right palms.
How sad is that though - that happiness for him is creating an illusion that others think him a successful trader who is just taunting our inexperience?
Do you think he also sends himself Christmas and Birthday cards?
Examples going back ten years of the DHW boasting about his "taunting". He actually admitted when somebody cornered him a few years ago that he used Califflla as a "trading id".
1. T...y_i..m - despite Roberts new IDS those posts are obvious but to investors.I am not taunting now and I WANT the hoopla to get bigger!!
2. Themanfromkolob - amazing chart pattern. ha ha stop taunting these idiots
3. Califflla - I did not post the taunt of delisting but I think it is very possible - we shall see.I always put risk in the equation and zippy never does
4. Hankandwife - Yes I am a califfla watcher and have watched this guy do the same - taunting you all but in traders terms he has been very accurate.
5. Dfuntiime - zip is not only the star machine here,he has proven himself the total fool.Calif used to taunt him as the stock went into freefall,now he just makes him look stupid
6. Matsonman - Most know cali to be spot on the last couple of years. I read it and he has taunted these novices,but the Ignore is the only way to go here
7. Biochenvestor - cali has been painfully correct on the stocks price movement and yeah he taunts while making good trading observations.
8. Elcajonsheila - dont post much here but califfla is by far the most informed intelligent poster here if he would knock off the taunting.
9. Thetanv11 - There are a few good posts here but the poster califla seems to be a favorite, yet ,do a search (as I did) - he is taunting , and Yes posting facts.
10. Masterncmdr - Look at the reponses to the post.cali has been taunting you with reality ? and this is all you can say ?
11. Williarnhales1 - Every day I've watched this poster( although I think its more than 1 person) take you all for a ride, all the while between taunts,logically calling the steps down.
12. Eastofggwy1 - There are many big investment houses that deny sub 5 dollar stock shorting,but many like mine at Tradestation will. He's factual , but is taunting you guys
You're fooling nobody with your childish suggestions that Qualcomm needed to offer "defense testimony" on the infringement allegation.
That would only have been appropriate had ParkerVision offered evidence a "reasonable jury" might have accepted as evidence of infringement.
Your constant bloviation fails to conceal the fact that ParkerVision failed to do so.
But as for your claim that -
[ their entire defense testimony consists of 3 letters; "YES" ]
you seem to be forgetting that you yourself unwittingly told us that TWO witnesses uttered those three letters (and no witness offered contradictory testimony) -
[ Budwin later asked; "...the baseband signal goes into the capacitor and doesn't fly by it.." Rezavi; "Yes" ]
I absolutely LOVE the tacit admission of non-infringement by ParkerVision attorney Budwin - that the down-conversion to baseband signal occurs BEFORE the alleged energy accumulation in the capacitor :-)
Absolutely. One wouldn't expect any buyout offers before big pharma knows for sure the uses for which Arikace will be approved by the FDA, EMA and Health Canada.
But I see no reason why any regulatory body would approve Arikace for anything less than the treatment of serious pulmonary infections due to susceptible strains of Gram-negative bacteria and Mycobacteria - assuming the NTM results due shortly do indeed evidence efficacy against NTM.
The winner of the auction one would expect to be triggered by a buyout offer would need to reflect in the offer price projected revenue from other pulmonary therapies delivered via Insmed's liposomal delivery platform.
But as for potential target markets for Arikace alone -
30,000 with Cystic Fibrosis in the US
44,000 with Cystic Fibrosis in Europe
50,000 with NTM in the US
30,000 with NTM in Europe
30,000 with NTM in Japan
630,000 with MDR-TB Worldwide each year
4,000,000 with fatal pneumonia each year (how many more with life-threatening pneumonia which proves to be non-fatal?)
Doubtless the vast majority of global pneumonia deaths occur from TB, AIDS etc in countries which rely upon foreign aid. But in ten years time the proportion who have access to Insmed's liposomally-delivered therapies could be far higher than is currently feasible.
Last July the BOD issued shares priced at around 50% of the average analyst valuation.
Given those analyst valuations, the short-selling which took the share price from its $14.30 high a couple of months before the share offer to below $10 after the news that Arikace had succeeded in its EU CF Phase III study was on the face of it suicidal.
I personally am in no doubt that the short-selling was done with the guarantee that the BOD would issue shares at $10 or less.
The problem we now have is that although the fair value of the shares even without NTM success cannot reasonably be argued to be less than $30, the share price will always reposition to the price at which the BOD issues new shares.
The big question is whether or not the BOD whose salaries we pay would put the interests of institutional investors ahead of our interests when it comes to pricing the next offering.
The problem could be that the market doesn't trust the Insmed BOD not to issue shares priced at $20 or less on the back of the NTM results.
Tampa, re your -
"The judge will have the redirect testimony and can dismiss"
- given that Urspond, who also reported what he heard in the courtroom, has never mentioned that testimony - and nobody else here has ever seen a single quote from that testimony which contradicts Prucnal's all-important admission under cross-examination - I guess investors will have to decide for themselves if your word alone is enough for them to risk their investments.
The objective of the new legislation is to "encourage" the FDA to expedite the availability of drugs where there is data "reasonably likely to predict clinical benefit" in "unmet medical needs for serious or life-threatening diseases or conditions".
The most effective drugs currently available to the NTM patient population require the patient to endure serious side-effects for a minimum recommended period of two years.
The most effective drugs currently available to the CF patient population are only able to halt deterioration in lung function for a month or two.
The FDA will have data showing that Arikace halted the deterioration in lung function in CF patients for a year (and counting).
What reason could the FDA have to refuse to use its new powers to make Arikace available to the US CF patient population?
Hopefully the data from the NTM study will be considered by the FDA "reasonably likely" to predict a clinical benefit in a second unmet medical need.
The FDA guidance -
[ The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.
Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. ]
An example of accelerated approval -
[ The FDA is approving Northera under the accelerated approval program, which allows for approval of a drug to treat a serious disease based on clinical data showing that the drug has an effect on an intermediate clinical measure (in this case, short-term relief of dizziness) that is reasonably likely to predict the outcome of ultimate interest (relief of dizziness during chronic treatment). This program provides patient access to promising drugs while the company conducts post-approval clinical trials to verify the drug's clinical benefit ... ]
[ The effectiveness of Northera was shown through two-weeks in two clinical trials in people with NOH. People taking Northera reported a decrease in dizziness, lightheadedness, feeling faint, or feeling as if they might black out compared to those taking an inactive pill (placebo). Durability of the improvement in patient symptoms beyond two weeks has not been demonstrated. ]
And so you should. I would hope nobody here is attaching any importance to my opinion.
But facts are facts, no matter who posts them
And one assumes I have posted one or two facts which suggest a very bad outcome for ParkerVision. If they are not facts, why has nobody posted evidence which directly contradicts them?
Instead of hard evidence, all we hear is mind-numbing bloviation contrived to create the impression that contradictory evidence exists.
What I find most depressing about the DHW is the apparent inability of others here to mentally construct a profile of him.
1. He is so dumb that he has boasted about his profits from Shorting INSM for years without ever grasping the concept that a Short trade is essentially a normal trade in reverse.
Had he understood that he would not have posted the recent claim of covering a Short trade in order to free up "dead money" to invest in promising biotechs.
2. He tries to create the appearance of being a successful trader by inventing trades.
3. He is most active on days when INSM is in the red. We hardly hear from him on days when we see a significant gain in the share price.
If he was here to affect the share price he couldn't afford to be discouraged when we're in the green.
4. He has been hanging around this forum for over ten years, using a ridiculous number of ids along the way.
There is no financial incentive behind what he's been doing here. When you're as dumb as he is - boasting about non-existent trades, playing games with ids, and "taunting" are all the incentive he needs.
Tampa, re your -
[ AGAIN, this "yes" was clarified and put in context in redirect, totally debunking Neal's assertion that the QCOM circuit was a double balanced mixer, or that the downconversion occurs before the storage device ]
- how dreadfully unfortunate that the "clarification" of this all-important admission by ParkerVision's independent expert witness - "the double balanced mixer not only is capable of, it does, in fact, create the baseband before it hits the TX filter" - was not mentioned at the time, either by yourself or by Urspond in the notes you posted of what occurred when you were in Court.
Isn't it ALWAYS the way? The most important evidence of all - and both of you forgot to mention it :-(
"a reasonable verdict based on sufficient evidence and testimony"?
Judge Dalton may not agree.
Here, in brief, are the four steps of the patented "method for down-converting a carrier signal to a baseband signal" Qualcomm is accused of infringing -
1. Receiving the carrier signal.
2. Sampling the carrier signal.
3. Accumulating energy via multiple samples.
4. Generating the baseband signal from accumulated energy.
Unless a receiver receives the carrier signal it cannot work. Evidence that a receiver performs Step 1 of the patented method is not, in isolation, evidence that a method of down-conversion infringes the method of down-conversion patented by ParkerVision.
The truth, as is obvious to any reasonable person, is that the onus was upon ParkerVision to produce evidence that the accused products down-convert to baseband signal via the specific COMBINATION of steps patented by ParkerVision.
As I have pointed out on numerous occasions, ParkerVision failed to produce evidence that energy accumulation is part of the accused method of down-conversion to baseband signal.
How could they - when ParkerVision's independent expert witness and a second witness both acknowledged that down-conversion to baseband signal in the accused products occurs BEFORE the signal reaches the device the expert claimed has the potential to accumulate energy?
Without evidence that the trademark ParkerVision energy accumulation step is PART of the accused method of down-conversion to baseband signal, all you have is evidence of down-conversion instead of evidence of infringing down-conversion.
Neither yourself nor Urspond - both of whom claim to have attended the trial - has ever claimed that ParkerVision did indeed produce the all-important evidence.
It would be pointless for you now to do so - unless you were also prepared at this late stage to add to the reports both of you posted at the time in this forum, evidence you would have to INVENT.
So the pair of you just bloviate.
[ The Secretary may approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, under section 505(c) or section 351(a) of the Public Health Service Act upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit ... taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. The approval described in the preceding sentence is referred to in this section as `accelerated approval'. ]
However ..... easier said than done.
The new legislation empowers the FDA to approve a drug on the basis of preliminary data "reasonably likely" to predict clinical benefit.
The approval can subsequently be withdrawn if the drug doesn't deliver.
But the big problem the FDA faces is that the shorter the development program, the less visibility regarding the safety of the drug.
For years now the public has only been exposed to a drug after long-term safety studies in animals. What reassurance could the FDA have without those safety studies?
I believe the relatively small number of drug candidates like Arikace for which there is already extensive safety data in the bag are Christmas-come-early - for FDA chiefs looking to demonstrate that a "new broom" will not be needed to achieve the objectives of the new legislation.