Summary comments:
1 - Since Thursday 29 March, about 48 million shares of Prometic have moved: ~45 million shares of PLI in Canada, and over 3 million shares of PFSCF in the 'States.
2 - Assuming that the remaining short position was <30 million shares, also assuming that 50% of shares traded were short, that leaves a short position of ~6 million shares.
3 - Ryplazim approval was widely expected, given the drug's efficacy and safety profile. Despite Prometic's added consultants and efforts to ensure success, the FDA denied approval:
— 'The FDA has, however, identified the need for Prometic to make a number of changes in the Chemistry, Manufacturing and Controls (CMC) section of its BLA. These changes require the implementation and validation of additional analytical assays and “in-process controls” in the manufacturing process of RYPLAZIM™ (plasminogen). While Prometic is expecting to complete said implementation and validation in April 2018, it will be necessary to manufacture additional RYPLAZIM™ (plasminogen) lots to support the implementation and validation of these process changes. Prometic expects to complete the manufacturing of the additional validation lots in the summer of 2018 and anticipates being able to provide the FDA with such new CMC data for its review in the fourth quarter of 2018, which is beyond the Prescription Drug User Fee Act (PDUFA) date of April 14, 2018. The FDA requested that such CMC data be submitted as an amendment to the current BLA and has invited Prometic to also submit the long-term (48-week) clinical data at the same time instead of through the originally agreed upon supplemental BLA process. This process will allow the FDA to consider granting full-licensure under the current BLA. If granted, this is expected to allow a faster sales ramp-up from launch than could have been achieved had provisional licensure been obtained by the current PDUFA date. The Company continues to interact with the FDA and will provide a further update when it is in a position to disclose a new PDUFA date. The FDA indicated that the submission of the new CMC data will not impact the previously granted designations, including the Priority Review Status, the Orphan Drug Designation and the Rare Pediatric Disease Designation for RYPLAZIM™ (plasminogen) for the treatment of congenital plasminogen deficiency."
— It appears that Ryplazim may finally get to market Q1 2019.
4 - Prometic's PBI-4050 agreement with SRAM was cancelled, resulting in financial losses.
5 - Positive Clinical Data from ongoing PBI-4050 study in Alstrom syndrome patients.
— PBI-4050 appears to be reversing fibrosis.
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Financing has always been Prometic's weak point. Now, Ryplazim revenue has been postponed by almost 1 year. Plus, the company has just taken a loss on the SRAM non-deal.
Obviously Prometic will need cash. Another distribution — the question is, at what price? Until terms are known, this may have an inhibiting effect on new buyers. Today's price may not be the low for 2018.
Jim
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Appended: An email from Investor Relations
' ... No, we will be able to continue using inventory for the patients we still have on compassionate usage. How ironic is this right? Over 3200 successful infusions, 100% resolution of lesions in 100% of the patients and yet we need more in process controls and assays. Do you really think the FDA would even think of allowing us to continue infusing patients if they had any doubts left about the clinical efficacy?
This was the earliest opportunity for us to disclose a likely delay to the point where we have taken the unusual step of pre-empting a final communication from the FDA on or around the PDUFA date. We are yet to receive a final answer from the FDA on the approval or not of the product. Based on our most recent discussions with the FDA around the late cycle review meeting which took place mid MARCH ONLY, we now have sufficient certainty that we will be unable to answer the final questions from the agency in time to meet the PDUFA date. This is due to the time involved in completing the final requested tasks. We had hoped to be in a position to come to an agreement with the FDA in time to meet the April 14 deadline for approval. As soon as it became clear that it would not happen, we disclosed th news that you have seen...
There are no problems with the product. We now have done more than 3200 infusions. The product has demonstrated solid long term clinical activity and tolerability. The FDA has confirmed that our clinical data are satisfactory, and our manufacturing plant and equipment have no material deficiencies. The areas requiring remediation all relate to controls and tests used at intervals during the manufacturing process. The FDA has requested additional controls be inserted into the process. We are confident that these can be fully achieved. Indeed, by the PDUFA date (April 14) over 90% of these changes will be in place.
Prometic recognises that Plasminogen has many additional clinical uses and is committed to ensuring that the production process controls are suitably robust, and fully to the satisfaction of the FDA, which will ensure that licensing for future indications can be achieved more smoothly.
The FDA is simply asking us to insert more controls to make sure that SHOULD there ever be a problem, that we would be to identify exactly where in the production process it would come from. Call it production process overkill, or extra safety but in the end, the FDA has the final word and we will put in place whatever is required to be in position to get the product approved.
The FDA requested that the new CMC data be submitted as an amendment to the current BLA and has invited Prometic to also submit the long-term (48-week) clinical data at the same time instead of through the originally agreed upon supplemental BLA process. This will allow the FDA to consider granting full-licensure under the current BLA. If granted, this is expected to allow a faster sales ramp-up from launch than could have been achieved had provisional licensure been obtained by the current PDUFA date. The Company continues to interact with the FDA and will provide a further update when it is in a position to disclose a new PDUFA date.
We will complete the task of implementing the requested manufacturing controls by the end of Q2. Thereafter, the FDA wants us to run 3 process qualifications batches all the way through to final drug product. Manufacture of the bulk product can be completed in a relatively short timeframe at our Laval facility. Thereafter, we have to allow time at our third-party fill/finish facility that part of the process will take several weeks to complete. The results then need to be written up and submitted in a final report to the FDA, which we expect to submit during the fourth quarter of 2018. Therefore, we expect the launch of Ryplazim will be in the first half of 2019. At this point it is not appropriate to speculate on a specific date, as the exact timing will depend on the speed of the FDA review.
There was no leakage of info or insider trading activities, certainly at least not to our knowledge, we ourselves fought until the last minute to come to an agreement with the FDA that would have maintained the original date. You may not believe me but that is a fact
We will get through this and make it right and not just for ourselves or our shareholders but also for the thousands of patients that depend on our drugs to get better...
Hope this helps somehow
Have a good Easter weekend
Best
Fred" |
