InvestorsHub Logo

Bob_LobLaw

12/12/21 5:42 PM

#426037 RE: Nick119 #426033

Last year they only issued 1 cert in last 2 weeks of year. I say if cert doesn’t come this week, it is not happening this year

ae kusterer

12/12/21 7:24 PM

#426056 RE: Nick119 #426033

So let’s suppose I am naked short 100 million nwbo, and in the last few weeks I am hearing that TLD, the paper, and MHRA approval may actually be coming soon( one example: see Nick119 post below). With biotech tanking last week , I figure its a good time to pile on NWBO , so I naked short sale 4.5 million shares in the last 22 minutes on 12/10/21. Then in the next two weeks I am hopeful I can cover closer to $0.60 , rather than the $1.20 of a couple of weeks ago.






Nick119 Member Level Sunday, 12/12/21 05:34:41 PM
Re: kfa670 post# 426029 0
Post #
426033
of 426055
I know you didn't ask me, but I do believe we will see certification in the next two weeks. If you look at the GMP site, https://cms.mhra.gov.uk/mhra/gmp , the frequency of certifications issued has been increasing and I believe that the MHRA has moved to remote-based certifications and has not halted the certification process due to COVID increase, as seen in their most recent certifications with the content of:

"The certificate is issued based on a remote inspection of GMP compliance during COVID-19 travel restrictions. A risk-based site inspection programme remains in force."

We know from the press release issued on the subject of HTA certification, that the physical site inspection was already conducted:

"The original inspection timing was delayed by MHRA due to their caseload; however, the week-long onsite review by two MHRA inspectors was recently completed. The final phase of the process involves receiving an official MHRA inspection report and taking any responsive actions that may be required. The Company currently anticipates that this process will be completed before year-end."

Based on the likelihood of gaps being procedural & documentation based, I believe they will still meet the anticipated timeline.