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100% agree
management has done a poor job depending on hand-to-mouth month-to-month retail financing sub the SP.
Thank you I appreciate your assessment
failing to disclose something is completely different from saying that, according to Les, that no news is good news and a bad MHRA review would be material, that would be outright lying. Also he said they are on track for fast track approval and he said that he looks forward of you leaving this board.
From everything that has been disclosed by NWBO its very clear that DCVAXL will be approved,
Outlook Therapeutics received a positive CHMP opinion from the European Medicines Agency for bevacizumab. That is a big deal since the EU is what? 15x/20X bigger than the UK. initially, their stock went up 35% now they are trading at the same level as before the positive recommendation.
NWBO will not gain more than a dime if our "brilliant" CEO Linda has not arranged non dilutive cash income for NWBO.
https://www.ophthalmologytimes.com/view/outlook-therapeutics-receives-positive-chmp-opinion-from-european-medicines-agency-for-bevacizumab
yes ?
eligible as in... national , MAA, first...
You should read the text - side note very carefully again
Yes Im aware the article is about established medicines/IRP pathway , but what I quoted is a side note in the article about meds that have never been approved /recognized by other RA's previously
There is only one first time...
All eligible national Marketing Authorisation applications submitted before 1 January 2024 that were awaiting first assessment
Im probably going to enjoy the return on my NWBO investment as much as your financial demise, after NWBO is bought.
are you seriously that stupid?
False again
No ASM is needed to return management's option/warrant package, the court's order suffices. Try again perhaps three times is a charm.
all your complaints are about what other posters may or may not have said here, none of those have anything todo with me. Its perhaps more effective to complain with those who have predicted something that did not come to pass.
Ps Just in case, I had nothing toto with the collapse of the Baltimore bridge
your reasoning is nonsense. If they were forced to hold an ASM then they can't come out and say that they may plan an ASM for the end of June. If their hands were forced then they would have sent the ASM proxy out to have one in 22 days. Period
Also if NWBO was sued to hold an ASM then that is a material event that needs to be disclosed.
If NWBO has nothing to show for at the ASM end of June (as Flipper suggests) then why not call the ASM on May the 10th when the 10Q came out?
With a proxy of 22 days we can have a nothing Burger ASM on June 1. Its very clear NWBO is waiting for big news before they call the ASM.
I admit that Les remark on late fall as the time period when they expect to be making an announcement about that (...), is highly confusing.
You really must be desperate to think MHRA is the same as EMA. And you are lying as well.
Yes the assessment timetable for new active substances and biosimilar products or existing active substances will begin after the validation of the application.
However, that date is January 24, 2024 and NOT as you falsy claim the date NWBO received news of the application has been validated March 7
Now the question is if NWBO has received an RFI. Yes or no. If they have received an RFI then they received it on April 13 2024 (80 days + Jan 24 2024)
In that case the date for approval news will be 210 days + Jan 24 2024= aug 20 2024. Most likely Scenario 1
From everything that NWBO and Les are communicating it seems that they have not and never will receive an RFI in that case the date for approval news will be
at Jan 24 2024 + 150 days = June 24 2024 Best case scenario 2
If the MHRA would still send an RFI today or this week, well than we are looking at fall 2024. Worse and most unlikely scenario 2.
OTH the date Of January 24, 2024 the Company received notification from the MHRA that the MAA had passed validation could be the date the application was validated. In that case, the approval will be confirmed on August 20, 2024.
NWBO has not received an RFI. No news is good news as Les said. However Les, NWBO anyone can not exclude that an RFI still may come at any day. If that's the case we will see the outcome of the approval process from the MHRA in late fall as what Les was referring to. Hopefully, we will never see an RFI.
And yes if the MHRA would send an RFI tomorrow then that would mean a flagrant violation of their timeline approval process..
I have stopped listening to you years ago Thank goodness
nope what you are saying doesnt make any sense
Les can make a wild estimate of when they will receive news of approval it has nothing todo with NWBO not hearing anything so far. His estimate is probably way over the top. Could NWBO still receive a RFI... everything is possible but that would mean the MHRA is almost 2 months behind on their own schedule.
I think Les is calculating that they still MAY be receiving an RFI and then you get to his fall deadline this year...