RE:RE:RE:RE:RE:News This is a learning curve and the Trial will effectively re-boot - much as it did during Phase IB.
All 12 patients were under-treated by the Study Treatment from between 30.9% and 154.3%. The errors that caused this are apparently now understood and should be addressed in all future treatments but those are big percentages and even the least under-treated will have received very substantially less than the treatment intended. It is some testament to the potential of TLD-1433 in NMIBC that even with significant and universal sub-optimal dosage and activation and after only one treatment % CRs still rival the best efforts of many competitors.
To compound this an incorrectly-drafted Clinical Protocol resulted in 4 patients being mistakenly withdrawn from the Trial before their second treatment - which is a shame for them.
Of the 8 remaining enrolees 3 have already received their second treatment.It appears that these also will have taken place under the same regime that resulted in the preceding universal under-treatments but on the positive side all 3 at least exhibited a response from their initial under-treatment and it is possible that at least one of them exhibited a CR at 90 days`. In any event it is hoped that their two treatments combined - even if both under-treatments - will result in positive outcomes for them.
The five patients yet to receive a second treatment have already exhibited a positive response to their initial under-treatment and now being lined up to receive the correct activation of the correct therapeutic dose for their second treatment should have every reason for optimism.
To the extent that Covid may have prevented more under-treatments in Canada and with the IND delay prevented the wholesale launch of under-treatments in the States the Company may have dodged a bullet.
It is now up to those undertaking Phase II to prove that PDT can be delivered consistently and effectively but the issues here relate to calibration and activation. There are no shortcomings in the compound itself and with this Trial and the current preclinical work on GBM in Toronto and NSCLC at Roswell there remains a bright future for TLD-1433.
Anyway at least we now know the reasons for the current sp and for RW`s continued buying.