Thursday, July 24, 2014 2:06:20 PM
Pyrr, in post 15932 you state you would be interested to become NWBO Communication Director in exchange for a large stack of warrants. But above you indicate that shareholders should just be happy with the amount of info we have to date, and just wait for results. That could make your job as Communication Director pretty easy if you therefor would foresee NWBO not posting any more PR's until FDA makes announcement about the L trial or until topline results of L trial are released (2015 sometime?). Or in regards to Direct trial, no PR's until Phase II has been completed and its topline results are known (in 2015 sometime?).
That would be a long time to keep shareholders in the dark going forward.
I am a bit torn in wanting to hear more from NWBio in PR's, because I realize that if they accidentally disclose something they should not regarding the L trial, it could jeopardize it. Understood. So they need continue to be very careful with that.
You have my curiosity when you state the "we have already been given too much". But I am not going to ask what that might be, because if this is indeed correct then I do not want to highlight it.
Regarding "what exactly do I want to know": actually I think there is a lot of info that NWBio could make public without much risk of the info being twisted or putting the L trial at risk.
They might be able to provide some official updates regarding:
1. Have any patients been treated in Germany yet under the Hospital Exemption self pay? How much is NWBO looking to charge for such self pay patients? Lump sum upfront?
2. Provide some update on any progress being made with german negotiations on hospital reimbursement (certainly they could give some kind of update).
3. Recent NWBO posted in a PR that 7 additional centers would be initialized in Germany in JUNE AND JULY 2014. I would expect NWBO to provide a PR soon with an update on whether these 7 sites were added in June & July, and which cities/locations?
4. NWBO could provide an explanation why they are adding sites in Germany to the L trial, and why they believe patients will elect to join the L trial there despite the risk of initially just receiving a placebo .... when they can get treatment under the Hospital Exemption instead (soon?).
5. NWBO could provide an indication on whether the Hospital Exemption in Germany is seen as just a stepping stone to getting better access throughout Europe. And how they plan to go about this moving forward. Which countries next? Update regarding Great Britain? Other euro countries?
6. NWBO could provide a formal statement regarding the Trial Expansion. Have they indeed already made a decision to expand the trial? A little bit? Is the 348 number correct? Is the pspd cohort indeed 72 and will remain 72? NWBO could provide their insight regarding this pspd cohort (why needed, when added, why added). Impact on timing until L trial completed.
7. Is the L trial Primary Endpoint date of September 2014 as shown on ClinicalTrials.gov still correct? How does this jive with the full enrollment not occurring until end-2014? If this info is old info on clinicaltrials.gov, then why does the company not keep this more up to date?
8. NWBO could inform the shareholders that it has made a decision to hold off on any additional PR's regarding the Direct trial until certain trigger points (ie completion of Phase I or completion of Phase II) due to the MD Anderson situation or due to the ambulance chasers or both. Or NWBO could state that it feels it can and will continue to provide updates regarding Direct whenever they feel it is warranted. In other words ... should the shareholders expect to be left in the dark about Direct trial early observations for quite some time to come, or could we expect some more updates over next weeks/months?
9. NWBO could likely provide some updates regarding enrollment in L trial. Such as they have done in the past (where they indicated they are expecting to add approx 20+ enrolled patients per month). Could NWBO provide an actual enrollment count as of year end 2012 and 2013? Or would even providing this info potentially jeopardize the trial? In the past NWBO had provided some limited info about enrollment, but also indicated it would provide additional enrollment info to shareholders in the future. Well ... why are they not providing ANY additional enrollment info? How many of the total trial enrollment are they expecting to come from Great Britain and/or from Germany?
10. NWBO has remained silent regarding 1st interim efficacy being outstanding or pending. In my opinion, it would seem like they could provide some explanation or indication. They could even state that NWBO did not receive any 1st interim efficacy recommendation (just a continue on safety), and that in the meantime NWBO no longer feels like it will receive any efficacy recommendation from 1st interim.
Recent NWBO News
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2023 08:36:14 PM
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