Replies to post #690932 on NorthWest Biotherapeutics Inc (NWBO)

[dstock07734]

meirluc,

This is far too conservative. Recall what happened to Roche's FDA filing for SC Tecentriq last year. The filing was rejected because of technicality issue. One week before PDUFA, FDA notified that Roche needed to change their filing package to meet the new CMC criteria. How could a simple technical issue take such a long time? Now Roche had the approval from UK and EU. The revenue will start coming. According to Roche 1st quarter report, the SC Tecentriq has PUDFA set on September 15 if I am not mistaken. What happened to Merck's SC keytruda? I don't recall TLD from the p3 trial has been released yet. Would Merck like Roche to take the thunder?


https://assets.roche.com/f/176343/x/cbba56da34/irp240424-a.pdf

From the publication of the Nature paper and the news post from Oncovir, can we sense the positive correlation between the two company? From my understanding about the following article, it seems like good things are going to happen to Oncovir soon. Likewise NWBO.

https://gritdaily.com/cancer-therapy-oncovirs-hiltonol/

We can also estimate the approval from another angle. The following is the ADC trial which has AZN, Merck, and Daiichi involved. IMO, the results are lackluster in comparison of those from Seagen. After the ASCO presentation in June last year which had the data about 132 patients (the target is 145 patients), both the primary completion date and study completion one were moved to June 1, 2025 (conveniently IMO). I suspect the reason is simple. The lackluster data from the Daiichi's ADC in combination with keytruda would make Merck investors question if the deal between Merck and Daiichi was highly overpriced and shake their confidence on whether Merck can circumvent the patent cliff. Merck must have something exciting to lessen their investor's worries about patent cliff. It has to be something happening soon.

But as someone mocked me before, I could be in La La Land. Take my post just for fun.

https://classic.clinicaltrials.gov/ct2/show/NCT04526691
https://www.onclive.com/view/datopotamab-deruxtecan-plus-pembrolizumab-displays-efficacy-in-advanced-nsclc-with-or-without-chemotherapy

[exwannabe]

1. The 150 fast track started with the MAA submission on 12/20/23

Your assumption. NWBO did not say this (even though they know when the clock started). There statement does not preclude that they were issued a Request for Clarification that they complied with and was certified in March. If so the clock start would probably be on March 4.

Even before 2024, MHRA decisions were not rendered more than a year from submission.

In 2023 (through Nov) the MHRA approved 9 new products that were not rubber stamping EMA approvals. Of those 9, 5 took over 400 days.

But I do like the general world -view that approval is prior to the ASM. Only 1-1/2 months until we here biosecinvestor explaining how it should never have been expected by then and it was just shorts projecting false timelimes.

And will repeat come Sep when the more reasonable timeframes come to pass.