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Reefrad

05/11/22 7:00 AM

#470779 RE: Fireman02360 #470771

It all depends on how much progress they have made with regulatory work during the past 2 years. I am confident they weren’t just twiddling their thumbs waiting for an article to get accepted. How much progress has been made is key. Regardless, this treatment has now been proven effective. It is no longer speculation. Therefore I could see buyout happening if no other viable option existed in terms of financials. This would result in us not realizing the full potential value but at least a part of it.
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ilovetech

05/11/22 9:41 AM

#470920 RE: Fireman02360 #470771

Fireman - That's a very valid question, and an area that others here may have better answers to. Rafreed's reply is pretty reasonable imo. The company has been at this so long, even outside the conventional timelines, that it's not unlikely, but rather more than likely, that we see an expedited approval. I'm going to offer a different angle on this one, which harkens back to the disasterous blow to the FDA'S credibility has taken over it's handling of Covid. IMO, the FDA desperately needs a credibility infusion, a win if you will. It's been over 20 years with the same SOC. Yeah, I understand and believe that the FDA creates that environment to allow the money machines to keep going. But this treatment, perhaps more than any is exactly what they need to push through to justify the agency's existence. Plus, the FDA'S own Oncology Director used DCVax as the model blueprint for how the agency wants to review trial designs going forward. We know that a company of 30 people or so is not designed to function as a full blown pharma company.

The plan has always been to build out a successful treatment on all fronts and sell when the offer is too good to refuse. I trust LP has the gaming skills to have survived so many years against all odds, that the suitors should understand that she's not going to take anything out of desperation. The next six months max, we should see a conclusion to all this.

JMHO
ILT
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dennisdave

05/11/22 12:29 PM

#471122 RE: Fireman02360 #470771

I think LP is still counting on a significant increase of share price value after the journal publication, PR of met endpoints changed government website with amended SAP and PR of MHRA submission request of approval. After that, they can seel the last 25 million in shares.

I really do not hope the ASM agenda will say an increase of authorized shares at this point...

Btw 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 now that Northwest has submitted trial results they are legally obligated to update the clinicaltrials.gov website with the new endpoints. Unfortunately, that has never stopped Northwest from doing so.