Theralase Technologies Inc. V.TLT

Delays part of the FDA process...

[wildbird1]

Some debbie downer (some call them bashers) pretend that the delays caused by the FDA asking TLT for extra duration data is unusual...

In this link...Form 8-K for Immunitybio INC filed 05/11/2023

Item 8.01
It said ''The FDA requested that the company(ImmunityBio) provide updated duration of response data of the efficacy population identified by the FDA  in the company resubmission, as well as safety update.''

-Does the above sound familiar????

Note: Adstiladrin approval was also delayed by many FDA requests.

In short...
The FDA asking for extra duration of response data is part of the FDA BTD process.



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[tdon1229]

More likely, however, it's associated with management's assumptions.  Did you ever read the Forward-Looking Statements section that is included in each NR? Here's a portion that each investor should read for understanding: Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward

[Infinity]

Yes this Management lacks credibility.  You can try and justify all the delays perhaps place the blame on soneone else.  There is no other solution to a JV with a known pharma company to go ahead.

[Longholder99]

Other than delays caused by a worldwide pandemic (2yr), or FDA policy revisions, (both not in mgmt control) or an effort ( I believe) to manage funding incrementally to minimize dilution and maintain ownership of patents.  What material delays are you referring to?   I say this with one eye on the fact that pre BTD may have already been submitted.   

[Infinity]

Long holder, are you comfortable with all the delays.  Do you have other reasons to be complacent with the the management with rewarding themselves and being opaqe with their communications?

[Longholder99]

I am comfortable with the procedural delays when I consider that the test subjects stopped when the pandemic slammed the door shut. Causing us to be where we are now instead of where we will be in a year ot more.   I am fine with the financing happening the way it has having spoken to Mathew Perraton 2x.   Also due to delays from the pandemic causing extended periods of burn

[Dumbeldorfwhite]

This post has been removed in accordance with Community Policy

[CancerSlayer]

Agree...though incremental steps can be slow & painful, they often are externally influenced & internally calculated for the betterment of patients & shareholders, respectively.  I also agree that the pre-BTD has already likely been submitted.  Any kind of announcement re: a "pre-BTD" submission would be short on substance & long on shareholder consolation

[Infinity]

Wild with due respect,  I think you are completely off target.