"have committed to the TO, however"
You do realize that even if everybody but you (including all tutes) have signed tender agreements, AVNR still could, and, in fact, would be required to, accept a better offer from "another big pharma"?
Anticipating today's post, CLDX did include a handful of sarcoma patients, including one Myxoid/round cell liposarcoma patient, in the Phase I trial of CDX-1401.
Best outcome was stable disease in a cholangiocarcinoma patient.
I think you are a bit too pessimistic.
I see (and paste) :" Estimated Primary Completion Date: November 2016"
That is completion of the primary endpoint - PFS.
The study completion date refers to the date they expect to collect the last data point. As OS is one of the secondary endpoints, that Nov 2018 is the date they expect the last death or patient to be censured.
Celldex does not expect that endpoint to be important in getting approval for this indication. They believe that PFS alone will get them full approval in both the US and Europe. So, if the trial is successful, look for an NDA in 2017 if they are correct.
If regulators decide it is not enough for full approval, they may still be able to get accelerated approval based just on PFS as they already had an agreement about this with the FDA.
Any DD would have to be just on public information unless they submit a written superior proposal that the AVNR board likes. The AVNR board would have announced it if that has already happened.
Correct, the board would not keep hush about another bid. Even if they did, there is nothing to stop the new bidder from making it public if they were rebuked.
"highly volatile until REACT results are out" " until then expect the pps to linger "
How can a stock be highly violatile while lingering?
No, not a major concern to investors.
No, the accelerated approval trial has relatively easy endpoints.
The latest treatment targeting EGFRVIII that Duke is trying to sell - EGFRvIII-targeted BiTEs
- We have solid patent protection on targeting
- Interest from Merck, BMS, Novartis, Amgen,
Treatment with i.v. bscEGFRvIIIxCD3 yielded extended survival in mice with well-established intracerebral tumors (P
" but greatly de-risk trial"
Why does Oppy think that? METRIC goes from an FDA-approved accelerated approval trial that needs only meet one of two endpoints (response and PFS) to a trial now with requiring a successful PFS endpoint. The sample size remains the same. Expanding into Europe does not de-risk (especially if they include eastern Europe).
Funny that Oppy highlights response rate from the EMERGE trial when with these changes ,response rate no longer is a primary endpoint!
Furthermore, response from the P2 trial is defined differently in this trial. The confirmed response rate (as was to be an endpoint here) between control and glemba was much closer.
"Study design now mirrors P2 EMERGE design more closely. "
I don't see that. Looks like they moved away from the EMERGE design by relaxing some of the exclusion criteria (eg the taxane refractory requirement).
Right, all that noise you hear from the big holders means this deal will never fly at $17/share.
ESMO 2014 Press Release: Immune Checkpoint Inhibitors Provide Antitumour Activity Across Malignant Diseases
"There are at least eight anti-PD-1/PD-L1 antibodies in clinical development, spanning phases I to III. These include nivolumab, pembrolizumab/MK-3475, pidilizumab and AMP-224 targeting PD-1; and BMS-935559, MEDI4736, MPDL3280A and MSB0010718C targeting PD-L1. In addition, the preclinical and early clinical development of inhibitors against other immune checkpoints, such as TIM3, LAG3 and VISTA, and against costimulatory molecules, such as OX40 and CD137, are underway."
"So I would have to deduce that this was planned and the offering @ 11 dollars for 18 million more shares was to help provide the liquidity for this offer,.."
Why would AVNR need more liquidity if they are the ones being bought?
"1.The final numbers will be even better because ..."
Add psychic to his list of accomplishments.
1. "18,000 new cases of GBM in US per year (source Roche 2013) "
That figure is much higher than derived from the database that most people consider the best source:
the "Central Brain Tumor Registry of the United States". Even Roche quotes from this source in the press releases I've seen. Could you tell us where Roche used the 18,000 figure?
2. Shares outstanding = 89.6 million ....
You don't think there will be any dilution between now and when rindo hits the market?
3. Average price to sales (P/S) ratio in the sector is 10
That includes share prices of companies with drugs that are still ramping up in sales. Your estimate for rindo sales are at a peak, likely several years after launch.
If you look instead at buyouts of biotechs with recently approved FDA drugs, you will find oncology companies are going for around 3X expected sales in 4 or 5 years (eg ITMN, ONXX)
If you reduce the GBM population per the CDC, and revise downward the Price/sales ratios per recent buyouts then you would get a present-day value of rindopepimut closer to the mid single digits that analysts have derived.
0. "you are committed to surrendering your shares for $17/share regardless of how this acquisition plays out."
no, you can withdraw your shares any time up to when the tender is completed
1. then you get the new merger consideration
2. if the board accepts the bid from another suitor then otsuka will return your shares
3. If the offer is negated Otsuka will return your shares.
Just a few problems with what you wrote.
1. "As soon as/if they get 50%+, the deal is done at $17."
No, the offer continues until the closing date. If, and only if, 50% of shares were tendered and not withdrawn at that time and all other closing conditions have been satisfied can the offer (and then later the merger) be completed.
2 "Nothing can happen
until Dec 15" The tender offer can begin anytime.
3. "In the meantime,
other offers may come in." True. They can come in after Dec 15 also.
4. "Ostsuka could have 50% contracted for already"
True, but very unlikely. Officers and directors and maybe a couple of large institutional holders could have signed tender agreements, but to round up the full 50% would be silly and possibly counterproductive for the acquiror (likely leaks).
5. "If so, expect a court fight if a higher bid comes in."
The tender agreements (if any) will be structured so that they expire if a superior bid is accepted. Will not deter other bids.
1."so they the DOCS pushed the MTD to very high levels "
The DOCS pushed because that is what the protocol in the trial called for.
The deadly doses were 16 to 25% higher than the MTD.
2. "they died of Complications of Chemotherapy not nesceassarilly of Immuntherapy"
Indeed, the patients had ceased any previous immunotherapy regimens and were taking only the chemotherapy (targeted) that is Glemba.
3. "keep in mind they get COCKTAILS of drugs"
Not while they are in the trial. The investigators did not think it so hard to believe the deaths were related to Glemba.
4. "Sepsis related deaths are uniformly related to CANCER routinely,,"
Not so much for melanoma. When it does develop, blame neutropenia (a side effect of the treatment) as was the case here.
"..You know that!"
Indeed I do. Reread the first sentence of my post - the message is more a satire of another "reading between the lines" post from long_ than a criticism of the agreement.
If you like only happy news, check out the part of the agreement where BIOSYN is forced to agree that they have checked out CLDX and are qualified to say the shares are a good investment.
More highlights that probably tell us nothing about CLDX and its rapidly aging collection of compounds:
4. "Celldex may also terminate the Amended Supply Agreement upon sixty days’ notice in the event Celldex ceases further development of rindopepimut."
Why would CLDX insist on this protection if they didn't realize that Rindo may never be commercialized?
3b. "..."Subscription Agreement pursuant to which Celldex issued to BIOSYN, as additional compensation, 152,172 shares of common stock of Celldex, 50% of which are subject to a one-year lock-up agreement. …"
If CLDX is undervalued, as is chanted every day here, why would CLDX want to pay with equity? Why would CLDX feel the need to force BIOSYN to not immediately sell the shares?
5. "Celldex has agreed to order KLH exclusively from BIOSYN."
Why does CLDX need to pay $2 million just to buy product from BIOSYN and then not even be allowed to shop around? Kind of like paying $50 to Costco for membership and being banned from Sam's Club.
What if the sole supplier runs short? Does CLDX know that sales will never amount to much?
For those who cannot access the article, the original ASCO posters from 2010 available at CLDX website contains most of the key points.
Some things to remember from when the data were first presented:
1." PFS =18.0 wks for pts with gpNMB"
Strong selection bias here as the tumors of less than half the patients were tested for GPNMB and these patients were selected based on performance on the trial. If you look for GPNMB in only the best performing patients then where you find GPNMB you will find the best performers.
As was later discovered in EMERGE, GPNMB expression is quite common in this population so most of those patients in this early trial who performed poorly and did not have their tumors tested were in fact likely GPNMB positive.
2. "- ORR ranged from 15% to 33% depending on dosing"
The 15% is at the dosing picked for latter and from the overwhemingly majority of of patients. The 33% is for just 2 of 6 patients at a more frequent dosing schedule.
3a."doc would use when ALL ELSE HAS FAILED"
You know docs dosing above MTD? Is that after they fail at the approved dose?
3b "exceeding MTD so they were TRAIN WRECKS"
The patients did not receive more than the MTD because they were in any worse shape than the other patients. Just bad timing on their parts to enter the dose escalation phase at the end.