Those who are talking about $10 are simply wrong. If Neuvax works, price should be much higher. Of course, if it doesn't, than it will be difficult for this company to survive.
I can only see $10 as a possibility in a sellout by the management, where they will gift a few bil in savings to Roche and gain a few mil as a side deal to themselves. I've seen it happen with Immunex. If they do so, not only I will vote against, but i will also join a lawsuit that would surely follow.
$38,43 and even $50 are much more realistic numbers, if Neuvax truly works.
1. run a bigger phase II study.
2. run a study with herceptin as soon as possible, not dilly dally until a year ago
3. tied option grants to performance
4. not hire the "dream team"
5. spend money on more innovative stuff, NOT just passive immunization, which is basically 19th century technology with maybe 20th century twist.
I am still long a smaller amount of stock for the offhand chance that it might work, but give it 50:50 at best.
I see a January filing pertaining to Dec 2015 ownership of 9 mil shares, which was 5.6%.
hardly a major investment ($11.25mil) for a 4.3 tril asset company (0.00026%)
Total institutional-18%, which is VERY low.
If chances of GALE succeeding in trial are high, why NO institutional investor invests in it and why the stock is at $1.25? Mr Market seems to have no clue about great chances of neuvax.
Either chances are high and stock price is thigh or trending higher or chances are low and stock is declining and/or has a low price.
Riddle me this.
this is just nonsense, mostly, since to determine if vaccine is toxic, you need a few days trial, since this could be COMPLETELY separate from efficiency trial.
In fact, serious companies determine the short term toxicity of a compound up front, using very high doses.
In my opinion, they just wasted a lot of time dilly-dallying with lower doses.
why didn't they start with the high dose anyway? it's not that it is a toxic substance. the whole phase II planning was bad and allowed too much ambivalence about the results-almost like they did not wanted a clear answer.
regarding multiple booster injections-this is just laughable. Any immunologist knows that in most cases you need boosters for vaccines. the only question might have been-how many, that's it. In addition, why didn't they have had 300-400 patients in that trial, then they could have gotten stat significant p,0.05 and were able to ALREADY apply for a breakthrough/AA status. They were cheap and it backfired, basically.
from my perspective , Dr. Mittendorf has a pattern of engaging in many trials where the results are not clear cut. It is probably OK for academe, but NOT OK in commercial clinical reaseacrh.
Look at serious (large) companies. yes, they spent a lot of money on large trials, but when trial sfinich , they get a clear yes, no answer, NOT a maybe.
it is impossible to do a true placebo controlled trial once the drug/etep is approved, even conditionally.
To do so would be unethical because you have to test against the current standard of care.
There will be no volunteers.
The best you can do, which is either planned or ongoing, is to do a trial using DMD patients with mutations in a different exon. They would be unaffected by etep and can serve as a control.
are you kidding?
this stock was at about $40 last year (Dec 29), before anything.
it might open at $50-60 if approved, but will go up to $75-80 within a day or two.
Longer term max market cap is probably about $10bil, but it will probably stabilize anywhere between 3-5 bil first, if approved.
I don't know where they are tilting, but NOT approving would be a direct challenge to all stakeholders and a holier-than-thou attitude that might open the whole organization to unwanted consequences.
Conditional approval is safe, considering a pressure from Congress, DMD patient's caregivers and drs and allows for a withdrawal mechanism in case if etep will totally fail later on (not that I expect it to). Monetary allocations from insurance is small as well due to it being a rare disease, so insurance resistance is not a factor, I assume.
I generally agree, but what about Mr. market's ability to sniff out the results?
GALE is in the doldrums for a while, although off of the 60c lows.
So, if success is almost guaranteed, why this stock is not appreciating?
Abbvie buys phase 1b biotech Stemcentrx for 5.8 bil PLUS potential another 4bil under some conditions.
Phase 1, people. 10bil!
Well, it is because first class VC investors like Peter Thiel are behind it and probably some undisclosed yet results, but how convincing phase 1 results could be?
Anyhow, they had 300mil from Vcs, so their trials are probably well populated.
GALE, with so many potential great meds is in the doldrums still at 260 mil market cap.
of course, but not at $14.8, but at $30-45, so it could be as little #$%$6 mil shares.
I find the whole thing fascinating.
what is this volume signifies?
I hope that smart shorts already covered at $8-12-they had multiple opportunities to do so.
From $40 to $10-nice short.
Now, risk favors a long position, otherwise it would be just incomprehensible.
1931 June 17 $20 calls traded today
1643 June 17 $30 calls traded today
3576 (!) Aug 19 $30 calls traded today
It looks like someone is thinking that decision would be delayed in to July-Aug.
they probably sold both $20 and $30 June calls and bought 3.5 k of Aug 20 calls.
If drug is NOT approved, they will lose less than about 0.5/call or about 180K.
If drug will be approved before June 17, they will make about 1.6 mil, nice risk/reward ratio there.
If drug will be approved after June 17, they will have sold calls annulled, resulting in about 600k immediate income and 944K risk in remaining calls, so about 344K uncovered risk after June 17.
Smart trade, in my opinion
exactly..first of all, stability of the miniprotein could be dramatically different.
if protein is highly unstable, it could be underestimated. Without a barrage of antiproteolytic agents, wild type p53, for example, is difficult to detect. i seriously doubt that they did not let this one slip, especially since there is a contradiction between IHC/IF/RNA level and WB level.
Just use more proteolytic cocktails, darn it!
there is a contradiction between IHC/IF and WB data with WB shoing lower %.
I submit that their protein sample might be partially degraded, therefore showing lower protein % than RNA level and IHC/IF predicts. This is supported by neuropatologists who upon looking at slides thought that they do not indicate Dichenne, but Becker's (which is basically what this drug can achive in theory).
I agree, with her words about RNA being produced and type 2 errors needed to be avoided in such situations.
1. type 2 mistake is possible (this is a very important reservation), but should be avoided as a priority.
type 2 mistake-when active substance is deemed inactive.
2. RNA for dystrophin AFTER etep action IS being produced, no doubt-her words.
Whether ENOUGH protein is being produced-this is where the argument is most intense.
From my perspective, western blot might be a suspect because proteins can degrade during biopsy and sample preparation, less so in IHC/IF setting because sample is typically instantly denatured/fixed.
To do a western blot, you have to lyse cells in detergent and sometimes this lysis activates proteases, it is just a known fact, so it is ENTIRELY possible that RNA level is more informative than protein as determined by western blot.
Will see if it comes in further discussion.
Here is my take:
Apparently, there is a contradiction between what western blot says (~1%) and what IHC (or IF?) says (more like 4%). FDA says that western blot is more accurate and the only method to consider.
In my opinion, and I have done many hundreds of western blots IF and IHC samples, the answer to which technique is most accurate is not necessarily crystal clear. Why? Because WB tends to underestimate or not count at all molecules that run lower than expected MW (sometimes they present as a "smear").
Some of these smaller size proteins could be degradation products of a mini-protein, but still able to function to some extent, or at least there is no data that they absolutely can't.
IHC or IF does not suffer from this possible omission because (in case of monoclonal antibody) it is a single epitope binding, so even smaller size mini-protein products present in a "smear" will stain positive as long as the epitope is there.
Watch out for scientists make claims and counterclaims re this obscure point at the adcom.
I remain long for better or worse.