Agree..... consumer awareness and doctor awareness of different aspects coalesce... after which, an event could lead to a precipitous, tipping point in awareness (as shorts become atomic wedgies).
Volume kn*ob that is..... (so there, Yazoo)
Don't think so...... it's more about predicting response via renal markers, and eventually identifying ways to adjust dosage to increase the response distribution..... ultimately, this could expand the response distribution so all those bulk average weight loss rates increase (not to mention chipping away at the misleading ITT-LOCF regarding weight loss among drop outs that does not recognize the response distribution nature of lorq... c'mon people.... yes, you really DO have to take the drug to have any potential for benefits.... lorq drop outs due to AE's is like placebo... the MOA is a response distribution.... doses reflect threshold central tendency of population, not a volume #$%$!).
Dose response for lorq is not linear (like an amphetamine)..... Different people have differences in receptor sensitivity... the idea is to reach an effective body threshold that produces beneficial effects in the largest percent of population, while retaining safety levels across the same population...... so, if response can be predicted and dose adjusted accordingly, a higher percent of the population can obtain substantial benefits while ALSO expanding dose-related safety factors.
Oh yeah..... and it also extends the term of IP exclusivity.
(could be wrong.... worth 2 cents only..... imo, dyodd)
Meanwhile they accumulate for the bigger deal.....
BTW..... there is very limited ability to do this for C or Q. Those goofy combos ONLY allow method of use IP expansion, with ZERO composition of matter control.... in fact we have already seen how the combo generics are looming (and off-label combined uses are obvious).
Contrast that to Lorq which can expand both to new indication (smoking, T2DM, etc.), adjusted dose for specific indications, AND in combination as method of use.
BP waits and abides..... squash, then hijack or cruise for yard sales.... not this time!
It's another step in the long term IP life cycle management..... a response to the continuous roadblocks and delays (BP entrenchment). The good news is it extends exclusivity by an increment... bad news for longs is it also shows how label or indication expansions are likely to roll out gradually over some X period of years as additional steps in retaining IP control. That said, shorts also have to sit on dead money.
Meanwhile, growth relies on gaining MD recognition and public awareness...... what happens when they get to that threshold level? Smart shorts will exit ahead (while whiny short infants cry baby, cry).
Build those positions for one fine day.....
Yes, little bunny..... tell us more about this interesting story....
(do you really think adding dyodd protects you from publishing accusations?).
FREDFRAMER...... still trying to frame, defame, and blame.
Always screaming about fraud..... but never any details..... WHY?
Probably not good to short a stock and then spread false allegations.
DYODD.... all day long (obvious, but no disclosure or common sense)
All day short spamming.... disclosure goes WAY beyond DYODD.
Yes, that detailed report is good information. However, given that the objections were unfounded, I'd still say, next time around they bring a stronger overall B/R case..... using some of the new data and more clearly presenting the extensive data set developed over all previous clinical (and non-clinical) studies. Beef up both sides and BE READY for subterfuge and unfounded attacks.
Plan for success, but anticipate outside agendas..... We have seen how people can get access to the regulators and raise unfounded (or entirely bogus) claims to support their own agenda....
The way to counter that is to address all issues already on the table AND to bring info that anticipates ANY other potentially manipulated issues... already raised or not. The C approval sets a bar for B/R comparison.... use the complete B profile to form thoroughly documented and scientifically backed B/R..... tick by tick.
Scientific basis and credible disclosure at each step.
Ask your doctor if this is right for you:
Most common adverse reactions include: nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%).
This comment really ticks me.... because I suspect it's true...... BP does not care about IP value of recycled goofy combos.... they do care about small molecule NCE that stands to own an entire fundamental market area.
If and when they break finally through..... coalescing.
You mean write a letter to file?
CA's initiate (file)
CA's bank 1/3
Once it hits step 3, the defendent starts spending money..... chump change or handled by internal legal group for the likes of Kraft-Heinz...... but what percent of cash flow is it for a small goofy combo biotech?
You mean small molecule disruptive IP can't prevail against the BP elite.
If that's not what you mean..... try to actually say something meaningful.
Yeah, it's obvious you have nothing but an agenda.
It's not about the litigation alone.....
It's the ratio of litigation costs to cash flow....
Got's to pay those attorneys one way or another.
That's the way it looked and smelled.... thanks for the insight.
It's also why I think they need to come in with an airtight case on safety (one with little room for agenda interpretation).... and also bring additional data on benefits side. T2DM still being the big one and bring it as a beneficial side effect first (with data) before going directly to approval for that indication.... all imo, of course.
Not just about objections, imo..... boost the benefits side with additional data..... reduce the risk side to increase overall B/R..... the basis for approving Contrived... the complete profile sits there asking for comparisons.
Ok, here's a negative word.... I suspect they are holding the T2DM label expansion to maximize the patent life.... which means could take another couple years before seeking FDA review.
The core gets smaller (but they're all free at this point).
Data from supplemental studies nearly complete (and not provisional leaked data)..... now a profile for the GoofyCombo2 is sitting there for direct comparison.
ARNA event bias shifts upward again...... give it a little time to ferment.....
Let's see what happens.... holding core, waiting for right time to reload.