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And that's all that was. Support and confirmationthey are happy with intended amendments they requested and are open to recieving the re-submission with amended details. So the window for the time of that to be submitted plus our 30 days. It's not far off.
I hope end of the month but think potentially November with adjustments then submission so looking forward to it as much of the rest of us when we go clinical and found this a bit of fun!
Afternoon folks,
I've been playing with the new beta model of chat gpt that's linked with the current live bing search engine. It's excellent but was just inputting RNS and asking it some questions and here's my results:
Certainly. Based on the Regulatory News Service (RNS) update from Hemogenyx Pharmaceuticals on 14 September 2023, here's a theoretical timeline regarding when to expect further news on the subject matter:
1. **10 July 2023:** Hemogenyx Pharmaceuticals receives comments from the FDA concerning the Clinical Hold on the HEMO-CAR-T IND application.
2. **August 2023:** Hemogenyx responds to the FDA's comments with a detailed plan, supported by laboratory tests, to address the concerns raised by the FDA.
3. **14 September 2023:** Hemogenyx announces that the FDA has accepted their plan to address the concerns, thus lifting the Clinical Hold.
4. **Post-14 September 2023:** Hemogenyx will now work to complete the schedule of work set out in the plan and to resubmit the IND application as soon as possible, as mentioned by Dr. Vladislav Sandler, the CEO & Co-Founder of Hemogenyx Pharmaceuticals.
The subsequent steps will likely include:
5. **IND Resubmission:** Once Hemogenyx completes the required work as per the plan, they will resubmit the IND application to the FDA. The timeline for this resubmission will depend on the amount and complexity of the work required as per the plan, which hasn't been specified in the RNS update.
6. **FDA Review:** Upon resubmission of the amended IND application, the FDA typically reviews the submission within 30 calendar days as per its guidelines [➊](https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-clinical-hold#:~:text=Once%20the%20complete%20response%20to,hold%20satisfactorily%20addresses%20the%20issues) [➋](https://biotechresearchgroup.com/common-reasons-for-ind-clinical-holds/#:~:text=The%20FDA%20will%20review%20the,the%20clinical%20hold%20was%20lifted) [➌](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-and-reviewing-complete-responses-clinical-holds-revised#:~:text=The%20Agency%20has%20committed%20itself,so%20that%20they%20may%20be).
7. **Clinical Trials Commencement:** If the FDA is satisfied with the resubmitted IND, Hemogenyx can proceed with the clinical trials of HEMO-CAR-T. The commencement date for the clinical trials will depend on the FDA's response and Hemogenyx's preparedness to initiate the trials.
Given the information provided, further news regarding the FDA's review and the commencement of clinical trials may be expected within a few months post-14 September 2023, assuming that Hemogenyx can resubmit the IND application and obtain FDA approval swiftly.
Current MCAP: £345m
July went up 441m from 260m
August reached 520m
Sept 422m
And now 345m
So a fair bit over £20m haha, looks good for a rerate over here.
Neptune's sending sign through the grog!
Thanks mystic meg!
Now back to the studio with the weather 🌞☔🌩️
👌
I literally can't wait but can. Been here 3 and a half years aswell and after a wee slice look on being here much longer as that's what I've been waiting for. To see phase 1 trials and CDX progress licensing wise and then the potential juggernaut of viral/cancer treatments CBR. Yes please.
It is a very neat piece of kit. From what I can see costs about $50k per unit. Pretty amazing.
My neck of the woods that peil they are a great brewery
With BAIT being a subsidiary of HEMO this is probably a silly question and I believe I know the answer but looking for clarification. Would HEMO gain as the parent company?
The chat on this is so hilarious sometimes. The jokers know who they are, the others who constantly have to provide educated responses against it. In personally looking forward to the near future after two very good RNS and hoping that finally the utter trash 5-6% useless chat can just go. I have been here 3 years nearly four and it cracks me up the amount of time people try to talk down companies they are in to sew doubt. Always make me think what sad lives or interests really people lead to be so utterly obsessed. Sure like the rest I'm invested and obsession tilts on the edge of that but God it's mind numbing to contuosly watch the noise over and over. Feel like having patience and hobbies is something the rats on this board need to get a grip on.
Last words on that from me as the droning dribble that flows on here just makes what is an exciting biotech company clouded by the same old clowns. Doubt any of you have any first hand experience with terminal illness and being treated and if you did you'd be more interested in supporting some fantastic developments in the treatment for AML rather than your usual superficial nonsense. Ever had chemotherapy? It's a killer, in satire and truth. Been there, done that, and still live with the late affects today.
Hopefully HEMO makes me some money by getting it's treatment across the line rather than being driven into the ground by people with nothing better to do than chat *h*t.
...and nobody really cares, it's 5%...
Glad to have seen this come in today. That's good news. I'm just looking forward to seeing who the business partnership is with when it's formally announced after the IND has been accepted. Usually there are payments that come with such partnerships for phase one trials so we will hopefully have an increase in funds for the company and then the market reacting to the news too should hopefully get us on a real move back up. Has anyone been looking into comparative deals made over the last 3-4 years for phase one deals involving Car-T and similar therapies?
Anyone see in the news recently about a new outbreak of COVID in New York and the developing variants? Would be great if CBR came back with some info and applications to fast track human trials.
Just fire an email to Hemogenyx(at)Hemogenyx.com
Lets us know if you hear back.
Cheers JHFH for clarifying that 🙏
HT I was at the AGM. Vlad stated to the question of divelging what the letter said that they would not be doing that as soon as they receive it. He said in the AGM that they won't be speaking of the Information because it is sensitive. He said they planned to post an RNS once the clinical hold was lifted. Did you watch the AGM?
There is no benefits in speculating what day an RNS will drop as no one knows and there aren't any real prompts to support otherwise. I think it would be better to leave the 'is an RNS today or tomorrow or the next' chat off the board as it's sort of useless. Also I do not mean this in a rude way just stating the facts 👍
Haha shut up pumpky. Yes it's classified as it contains details specific to their process and technology. Stop being a joke. News regarding Car-T will be ready when it is days weeks months we will see. The company has other assets that may be spoken of over the next days, weeks and months too. Please don't talk crap it's exhausting we don't want anymore. Silence is better than rubbish.