RE:so tiresome Many where complaining lately about TLT management and never foresaw that Dr. Kamat/Dr. Kulkarni interview shooted at AUA and planned almost 6 months in advance! And TLT certainly has consulted specialized contacts throughout the years (UHN, MSAB, consulting firms. etc ...) to lay out its plan months in advance in order to execute it and advance in a secured way.
Being few weeks away from Breakthrough Therapy (application or designation), a small pp would be legitimate.
TLT management clearly informed us on April 26 about this:
"The Company is currently working with both a biostatistics and regulatory organization to compile a clinical data report for submission to the FDA in support of the grant of a BTD approval."
"Regulatory organization" most probably means the FDA, as per this excerpt:
FDA's Regulatory Responsibilities: Laws and Regulations; Product Approval
And as Wildbird1 mentioned, it's positive, not negative, that there has been delays past the initial "by end of Q1" regarding the submission of the Breakthrough Therapy application as it means TLT was most probably provided more infos, so the probable reason for the delay. Having only one opportunity to present data, better make sure we have it right, on that pivotal opportunity.
Again, that Dr. Kamat/Dr. Kulkarni interview shooted at AUA is extremely securing and telling, for 2 major reasons:
- Both Dr. Kamat and Dr. Kulkarni know where competition stands and what is needed
- Both Dr. Kamat and Dr. Kulkarni would not have given this interview if this treatment wouldn't stand a chance of approval as they don't have time to waste on losers and have better things to do of their precious time and loaded agenda.
Anybody whining about how long it takes to get there should rather be intelligent and humble enough to have this amazing opportunity to have access to such upside potential at these ridicule prices, with these recent signals (data, Dr. Kamat and Dr. Kulkarni, imminent Breakthrough Therapy, short FDA time to reply, etc ...), especially knowing that management also have skin in this.
When you look at market valuation graphs, you see biotech stocks pop up from nowhere and hit new highs over a very short period of time. This should be our time soon, if we get this Breakthrough Therapy designation as this will be the debut of an upward trend, that will see the addition of new CSS (up to 9), discussions with big pharmas, etc ....
Upward and onward.