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yes I agree NWBO should improve its communication.
But Im 100% convinced they will make it up with us very soon!
* What is the contractual deal with Advent for manufacturing in Sawston.
I agree with this one
. Where does the Flaskworks project stand.
we know work in progress
. Have they unblinded the database.
of course they have see my previous post. If they had not then they have misled us
. Have they updated the IND with the FDA
NWBO chose to disclose that when results are submitted as I have sowed they can
. What was the FDA response.
If negative then they should have disclosed no news means good news
. Did they have the pre-BLA meeting with the FDA.
That is not what biotechs disclose ex and you know it
. What was the response.
If negative then they should have disclosed no news means good news
. Have they started on a BLA.
That is not what biotechs disclose ex and you know it
. What happened to the IA that you said would happen in mid 2015 and have never followed up.
Ooh please
I however agree that NWBO should improve its communication.
I think this month 80% or max Feb 95%
80% in Jan
95% in feb
100% in march
lol well you already have the sunny beach to enjoy
I understand your frustration but Im really confident it will not be long until we see the publication. I promise
You have to have some faith in management. If you think they are playing games to keep us in the dark then that's not a good investment thesis.
Im confident that all of NWBO management wants this approved as soon asap and if they have concluded it's not feasible they would have disclosed that as SEC requires many months ago. Its good they did not
no legally there is not. I have been posting about this already and have little time to go over it but there is legally really not.
short. First of all, they have repeated in their 10Qs and K that they are seeking publication. If they have been declined over and over, over a set of time which is reasonable to get published then having that statement still valid is misleading.
If Im a listed company in Ice cream and I say I will manufacture banana ice cream then after how much time not doing so and failing to do so, is that repeated promise misleading? 1 year? 5 years? 100 years? 2 attempts, 5 attempts a 100 attempts? It's within reason that a prudent investor may expect the ice cream company to produce banana ice cream within a reasonable time for one can expect the Ice cream company has knowledge of how to produce banana ice.
There is a beginning and an end to a forward-looking statement and NO under safe harbor, the listed company can not keep saying and promising the heck they want. I have posted about this extensively a few weeks back and quoted several sources on this
if the article has been rejected then that fact should be disclosed for NWBO has stated they are seeking publication. In other words this:
You are saying its complicated and therefore you think discussing is a waste of time? That is your opinion.
hahaha
Deja vu is the same experience when you get deleted over and over for no reason what so ever lol
Ex knows sure knows how to find TOS button lol
out of posts will be back tomorrow
wrong
exwannbe I think I said before already here that almost all failed medical trials with any medical meaning will for future references and to inform the scientific community be published at some point. So congratz on finding two. It would not surprise me if more failed trials are published than successful trials.
However, most failed trials are published 2, 3 years after topline data was announced by the sponsor and are published by the lead investigator on a sunny Sunday afternoon.
I said therefore specifically all this trouble NWBO is going through to get a publication is only for a highly successful trial. As would with any other biotech..
ok thanks clear we agree
Im not really familiar with Novocure but how much revenue of its 400 million would remain if all of its GBM related sales would be left out?
Isnt that close to 80%? and what would the market perceive Novocures other upcoming devices if DCVAX L were to be approved?
I cant respond to PM but it is horrible I know
Btw he is a she :)
sorry I misread I though it said 6 months :)
not drafting the BLA...?
https://www.law.cornell.edu/cfr/text/42/11.48
Under § 11.44 d.3 the following is determined
“(3) For each submission of partial results information for a clinical trial, as specified in paragraph (d)(1) of this section: (i) If any amendments were made to the protocol and/or statistical analysis plan as described in § 11.48(a)(5) since the previous submission of partial results information, the responsible party must submit a copy of the revised protocol and/or statistical analysis plan”
So in case anyone was wondering why NWBO has not updated the clinicaltrials.gov with the new SAP, which we know exists from the EMA website. The reason for that is they are required to do so when submitting the trial results and legally not before that date.
sorry and thanks my son just jumped on my laptop lol
continue and again
So in case anyone was wondering why NWBO has not updated the clinicaltrials.gov with the new SAP, which we know exists from the EMA website. The reason for that is they are required to do so when submitting the trial results and legally not before that date.
https://www.law.cornell.edu/cfr/text/42/11.48
Under § 11.44 d.3 the following is determined
“(3) For each submission of partial results information for a clinical trial, as specified in paragraph (d)(1) of this section: (i) If any amendments were made to the protocol and/or statistical analysis plan as described in § 11.48(a)(5) since the previous submission of partial results information, the responsible party must submit a copy of the revised protocol and/or statistical analysis plan”
So in case anyone was wondering why NWBO has not updated the clinicaltrials.gov with the new SAP, which we know exists from the EMA website. The reason for
well said 100% correct
Thx for letting know
IMO the answer is yes they have
there is something else to consider. If NWBO had updated the clinical trial website they also had to update that the trial has been concluded and on what date. Had they done that then 1 year and then some later the NIH would be busting their chumps about updating manded trial results in the clinical trial website which could not be provided because as we know is on hold until the journal which is not a valid reason to hold TLD for, according to the NIH. If you don't update that the trial has been concluded then the NIH will not bother for it simply does not know that fact.
So there is that.
for anyone wondering what the next BS of the shorts will be after journal publication here it is.
100% correct and following that NWBO would then have to disclose those concerns
no nonsensical speculation Happyl has a good point here
I agree with you that its a lame excuse especially since NIH/FDA regs mandates biotechs such as NWBO to update their clinical trial website.