Long investors please read this post again.
md1225 Tuesday, 08/09/16 01:20:57 PM
Re: None
Post # of 70965
Long investors please read these two posts by Dan88. This is why I am so invested!
Thanks again Dan88 for posting this!
"I try to be polite today so Outside Lane won't find any reason to delete my post:
Since I don't want to tangle with any persons I deem to have no genuine intention or interests in this company, I would just like to point out one of the earliest speculations on the reason for the temporary patient screening halt in case people have forgot it:
DMC contacted FDA reporting extremely low event rate, which is much lower than expected;
FDA reviewed the information submitted by DMC and asked the company to halt screening for additional patients upon further notice while it conducts an investigation on what has really been going on and asking the company for some information ("certain information from the trial");
Confirmed the abnormally low event rate for OS, FDA takes its time waiting for more patient accruals (OS events) so that it can draw a reasonable conclusion with certainty;
The abnormally low event rate suggests patients in overall or in average live longer, much longer than would have been expected (recall LL's words?), which would be unethical to continue to enroll any additional patients since some patients would be put into the control, which would be likely inferior to the treatment arm;
In the meantime, the company cannot do anything but wait for FDA's decision. It cannot say the reason either because if it does, any patients already in the trial would have the right to ask whether they have been in the control arm, and if yes, they would have the right to ask for immediate access to DCVax-L vaccine. As a result, the trial would be ruined (or compromised)!
Any direct hint on the issuance of partial halt by the FDA would invite more questions as why, when exactly, etc., and the company may have to answer, which is exactly what the company won't do.
And this may be exactly why there has never been a definite information on the reason regarding to the current ongoing partial halt for additional screening, kind of "intentionally making some murky water" at the ire of investors.
The speculation above is today still one of the most reasonable theories on the reason of the halt, and yet some people are more than willing to forget it.
It explains why it has taken so long and it still seems to be no end of it.
Patience, ladies and gentlemen. It is out of control of anyone including FDA.
God willing, let patients live much longer than would be expected.
The current development regarding FDA's order to stop Juno's pivotal P2 trial due to deaths of patients has a very significant meaning regarding the future landscape of cancer treatments:
Cart-t as a group may have run into corner as the investment world finally come to a long overdue conclusion: this class of treatment is dangerous, cumbersome and costly, and its benefit/risk ratio is so unfavorable.
CI as a class has shown some success with very limited treatable patient population due to its nature.
Increasingly, more and more people will realize DCVax as a therapeutic cancer vaccine platform will emerge as a new and more broad blockbuster cancer treatment class due to its pristine safety profile and potential significant efficacy; with combinations with CIs, the platform may be potentially a cure for some cancer indications.
At this point of time, anyone who is debating on the purpose of debating is obviously naive or up to something that a normal investor will not do. So please stop engaging in such distractions, either from an old topic which has been discussed before with no new meaning but endless new speculation; something to do with fine prints pulled out from company's sec filing which have been covered in the previous discussions; and any other FUD such as tailored, sometime out of context copies and pastes of some selected FDA documents, and ambiguous subjects such as comparing a "lackluster device" to a potential blockbuster cancer vaccine treatment in any angle negative or ambiguous possible, etc.
The bottom line is if DCVax-L or D is proved to be better than any existing treatment in any indication in terms of safety and efficacy, it will be approved by FDA; even if L or D might be shown similar in efficacy and/or even safety to that of any existing treatment, it will still be approved by FDA as an alternative which can applied for specific patient populations.
While one may get carried away from a useless debate, he or she must always remember that at $0.5 a piece per share, basically the market has priced the company a failed company, the L trial a failed trial, LP a failed ceo, and all long investors failed hairballs, and nothing less.
Don't tell me the company will go bankrupt if you are genuine and have a bit biotech experience, only if LP had nefarious motive if you believe. A company like nwbo will not go bankrupt at foreseeable future, though it is a likelihood that the company will survive simply by diluting its existing share holders.
Nonetheless, as long as the potentials of D still exist, as long as there is still likelihood that L may still be used in combinations with other agents such as CIs even if L is proven a failure in brain cancer indication, a market cap of around $100 million will be normal, which will give you roughly $1 per share of stock price.
Not saying the company has not filed a BLA (rolling application or not), not saying the company has not sought AA, but what I am saying is the current situation indicated by share price has totally denied any possibility of those and regarded the company a failed company with a failed L trial.
It is then a natural, logic, reasonable and certain conclusion as long as investment is concerned: buy nwbo shares as many as and as much as one can afford at this option price.
It is either $0.5 loss or $30 gain or $300 gain.
It is my strong belief that there will be a major short covering coming within the next few weeks judged by current ultra-low share price (it should have never been at such a low price, no reasons, absolutely not), the closeness to a major revealing of many optional developments in the company, and the current on-going change of tide shifted from cart-t and/or CI toward DC-based therapeutic cancer vaccine treatment (cure) (note: it is my speculation)as well as the general trend of money inflow to biotech, which is on going.
Because unless shorts have bullets penetrated their heads making them totally blinded, a major short covering must be and will be coming, even if I prefer it not!"
Shorts indeed are in the process of covering. In order to control the price after some covering, they short some to maintain a price. My broker loaned out some 50k shares siting in my margin account to an unknown short a couple of weeks ago (who the hell would short at $0.5! Well shorts who started covering would just do that. Anyhow I will ask those loaned shares back in the near future). And new funds have been poured into small biotech like crazy though nwbo has not yet been benefited, but how long can this situation remain the same? No long, my friends.
Good weekend and good luck longs."
AI
