Member Info for MajorHayze

I cant imagine the FDA have any grounds to insist on further trails, after all they have had the requirements met through various phases and studies, to move the goal posts now would be very inconsistent and unprofessional. The suggestion of dosing and measurements would surely be theoretical, after all IMM and Avion have proved what is working and effective in practice? I would imagine the crux of the issue, is having a paper trial to show DD has been given to their guidance. I would imagine both Avion and IMM would have considered dosing to the highest degree in preparation for the trails and studies.. feels like a bit of a red herring at this point from the FDA..

Also received a response. Looks like they are waiting on an executive to finalise the update, also quoted "with our partner Avion", and acknowledges pressure on SP and references the "macro economic crisis" which is currently "putting enormous pressure on the markets"

Hold for RNS

He's devoid of any logic

Post-meeting follow-up (teleconference vs. WRO)

For meetings scheduled as teleconference
The teleconference meeting is the sponsor’s opportunity to obtain clarification on OTAT’s preliminary response. Due to workload, OTAT will not be able to address follow-ups or additional questions, via email or teleconference, after the meeting is held. If additional questions arise, the sponsor may submit the questions/alternative approaches or new data to the existing IND as an amendment for OTAT feedback.

For Written Reponses Only
Simple requests for clarification of OTAT WRO may be sent to the RPM within 20 days after receipt of the WRO. The sponsor should include their request for clarifications for all disciplines in a single follow-up request. Only questions of a clarifying nature will be considered, i.e., to confirm something in the WRO issued by OTAT, rather than raising new issues or new proposals.

Examples of such simple requests for clarification include:

Typos and misstatements by OTAT
The OTAT responses can be interpreted ambiguously and are unclear to the sponsor (e.g., “Did you mean A or B?”)
Examples of follow-up requests that are beyond clarification and therefore not appropriate:

Questions related to new information not included in the briefing package
Questions related to the adequacy of new proposals to address OTAT comments [e.g., new clinical trial designs, study endpoints, new patient population, new/modified assays, new preclinical study design, new materials (i.e., raw materials, source materials)]
If such questions arise, the sponsor may submit these questions, alternative approaches, or new data to their existing IND as an amendment for OTAT consideration.

OTAT will consider the follow-up request, and if determined to be limited to clarification, OTAT will issue a response in writing within 20 calendar days after receipt of the clarifying questions. If OTAT determines that a short teleconference would be the best format for follow-up, then OTAT will generally attempt to hold this informal teleconference within 20 days after receipt of the request for clarification. OTAT will not provide the sponsor with minutes for such informal teleconference.

During the meeting

The meeting is the sponsor’s opportunity to obtain clarifications on OTAT preliminary responses. As stated above, during the meeting the OTAT team will not be able to provide feedback on new information (e.g., new question, alternative approaches or new proposals to address OTAT comments) that was not previously submitted in the original briefing package.

Sponsors may choose to make a presentation at the beginning of the meeting. However, because OTAT staff will be familiar with the meeting package content and questions, OTAT recommends that sponsors forgo a presentation and use the allotted meeting time to obtain clarifications to OTAT’s preliminary responses to the sponsor’s questions.

OTAT recommends that time be reserved at the end of the meeting for the sponsor to summarize the major discussion points and action items.

Prior to the sponsor meeting

OTAT will send the preliminary response according to the timeline indicated above in the Table.
The sponsor is expected to respond to OTAT’s preliminary responses according to the timeline indicated above in the Table.
If the sponsor finds that OTAT’s preliminary responses and advice are sufficiently clear and complete to obviate the need for further discussion, the sponsor should inform OTAT in writing as soon as possible so that OTAT may cancel the meeting. These responses would then become the official OTAT responses to the sponsor’s questions.
If, after cancellation of the meeting, the sponsor subsequently wishes to follow-up on topics from the preliminary responses or pose new questions, then the sponsor should submit these follow-up or new questions as an IND amendment.
If the sponsor wishes to continue with the meeting, the sponsor should identify which of the original questions in the briefing package they wish to discuss and list the questions in the proposed order of discussion. As a general rule, the order of discussion is usually the order of importance to the sponsor. When referencing questions, the sponsor should use OTAT’s preliminary responses document numbering format.
After receiving OTAT’s preliminary response, the sponsor should not submit new questions and new information (e.g., alternative approaches or new proposals to address OTAT comments) not previously submitted in the original briefing package. OTAT preliminary responses are prepared after deliberative review, and usually include cross-discipline internal discussion, of the original meeting package and questions. OTAT will not have adequate time to review new material and have sufficient inter-discipline internal discussion necessary to prepare answers to new questions. Therefore, sponsors should thoughtfully prepare their meeting package and questions.
In some situations, a sponsor may want to develop new questions/alternative approaches in response to OTAT’s preliminary responses or discussion at the meeting. Such new questions/alternative approaches should be submitted as an amendment to the sponsor’s existing IND.

The sponsor’s meeting package should include a limited number of clearly worded and targeted questions that directly address concerns about the drug development programs. The number of questions in a meeting package should not exceed what can be reasonably discussed within the duration of the allotted meeting time. For a 60-minute meeting, a maximum of 12 questions (inclusive of sub-questions) would be considered reasonable. For example, Questions 1a, 1b, 1c, 1d, 2, and 3 would be 6 questions.

Written Response Only (WRO) is considered to be equivalent to 60 minute meetings. Therefore, the maximum of 12 questions (inclusive of sub-questions) is applicable.

If you think a majority shareholder, privy to insider information, can sell prior to disclosing said inside information to the wider market you're a bit of a clown really

Yet to see any "huge" sells, says a lot about the calibre of "investors" calling 4 figure sells, huge...

Exactly. Seems plenty haven’t a scobby about the process, purpose or next steps of a type C meeting. I hold

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otat-type-c-meetings

OK, this share price looks crazy wrong - why are people not piling in? Just taken a position after pondering and researching all morning am i missing something or is the market?

It went from 0.001 AUD to 0.003 AUD.

Now kids, how many times does 0.001 go into 0.003

Large 1m after hours trade popped up

Perhaps if those “LTH” weren’t slating people and being abusive purely for buying today they wouldn’t be getting it back in equal measures - food for thought, reap what you sow.

Seeings as it’s all about us vs them here’s whats next..

We make money, you don’t, the end.

Still loling? :-)

Ah yes - the BB, an investors primary tool .. lol there’s a reason generally BB are full of bitter LTH who don’t know a good time to buy and equally can’t cut their loses so endlessly haunt the grounds like a graveyard undecided as to whether the love or hate the stock they are holding

Being a LTH in this case shows nothing but being a bad investor.. so stop wearing it like a badge of honour and talking down to every new investor or face.. new interest is a good thing embrace it

So cut the nonsense and drop the hostility and talk about the stock at hand?

Yes - pure coincidence that a few new faces appear on the 2nd highest volume day in 2 years... must be.

Guess some are better at catching the turning tide then others.

Whilst you pretend you haven't been here since 20p.

Buy high sell low wasnt it.... Zzzz

"Us LTH" = bought high, hold for years to sell for breakeven and is rude to anyone who isn't 50% down.. quite tragic really.

But hey lets show you some respect... for no other reason then you've been posting on a BB for longer.. kudos!

Perhaps you could buy some manners if you've any cash left in your account - food for thought.